Last update 08 Nov 2024
Prednisone
Last update 08 Nov 2024
Overview
Basic Info
SummaryPrednisone, a pharmaceutical intervention with extensive applicability in the treatment of inflammatory conditions, ranging from allergies to arthritis to asthma, belongs to the corticosteroid drug class, which effects immune system suppression and the subsequent diminution of inflammation. Administration of prednisone is generally through oral ingestion, with both short-term and long-term treatment protocols being a possibility. However, as with all medications, prednisone has the potential to produce adverse side effects, including but not limited to weight gain, mood changes, and an augmented susceptibility to infection. As a consequence, it is indispensable to collaborate with a qualified healthcare provider to determine if prednisone is an appropriate and effective intervention option for ameliorating the specific inflammatory condition that necessitates treatment. |
Drug Type Small molecule drug |
Synonyms 1,2-Dehydrocortisone, 1,4-Pregnadiene-17α,21-diol-3,11,20-trione, 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione + [45] |
Target |
Mechanism GR antagonists(Glucocorticoid receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Drug Highest PhaseApproved |
First Approval Date US (21 Feb 1955), |
RegulationOrphan Drug (US), Priority Review (CN) |
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Structure
Molecular FormulaC21H26O5 |
InChIKeyXOFYZVNMUHMLCC-ZPOLXVRWSA-N |
CAS Registry53-03-2 |
Related
1,557
Clinical Trials associated with PrednisoneA Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study
To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL.
Start Date28 Mar 2025 |
Sponsor / Collaborator |
Postoperative Steroids and Recovery After Spine Fusion
This trial studies how well low-dose postoperative corticosteroids (FDA approved) affect patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) after thoracic and/or lumbar spine fusion surgery.
Start Date01 Mar 2025 |
Sponsor / Collaborator |
A Randomized International Phase 3 Trial of Imatinib and Chemotherapy With or Without Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or Philadelphia Chromosome-Like ABL-Class B-Cell Acute Lymphoblastic Leukemia
This phase III trial compares the effect of the combination of blinatumomab with dasatinib and standard chemotherapy versus dasatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (PH+) or Philadelphia chromosome-like (Ph-Like) ABL-class B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib in combination with standard chemotherapy may work better in treating patients with PH+ or Ph-Like ABL-class B-ALL compared to dasatinib and chemotherapy alone.
Start Date28 Feb 2025 |
Sponsor / Collaborator |
100 Clinical Results associated with Prednisone
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100 Translational Medicine associated with Prednisone
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100 Patents (Medical) associated with Prednisone
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33,278
Literatures (Medical) associated with Prednisone01 Apr 2025·DEN open
Unique endoscopic features of primary biliary diffuse large B‐cell lymphoma: A case report with literature review (with video)
Article
Author: Kameyama, Naohiro ; Ishigami, Keisuke ; Nakase, Hiroshi ; Masaki, Yoshiharu ; Kawakami, Yujiro ; Sugawara, Taro ; Nakamura, Tomoya ; Satoh, Shuji ; Sugita, Shintaro ; Takada, Yumemi
Abstract:
A 67‐year‐old man visited our hospital complaining of dark‐colored urine and upper abdominal pain. Magnetic resonance cholangiopancreatography showed stricture of the distal bile duct, and contrast‐enhanced computed tomography showed irregular thickening of the distal bile duct wall. However, no enlarged lymph nodes, pancreatic tumors, or other neoplastic lesions were apparent around the bile duct. Endoscopic ultrasonography and intraductal ultrasonography showed irregular thickening of the inner hypoechoic layer without the disappearance of the innermost thin hyperechoic layer. On the basis of these findings, we considered that the bile duct lesion was of non‐epithelial origin. Thus, we repeatedly performed bile duct biopsies from the same site under fluoroscopy to obtain a sample of the submucosal tissue. The pathological diagnosis was diffuse large B‐cell lymphoma, and the patient received systemic chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). After six courses of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, positron emission tomography‐computed tomography showed the disappearance of 18‐fluorodeoxyglucose uptake in the bile duct and endoscopic retrograde cholangiography showed improvement of the bile duct stricture. Endoscopic findings and repeated biopsies were useful in making the diagnosis of primary biliary diffuse large B‐cell lymphoma.
01 Apr 2025·DEN open
Dynamic endoscopic progression of gastrointestinal tract involvement in Langerhans cell histiocytosis: A pediatric case report
Article
Author: Li, Zhongyue ; Liu, Bo ; Zhang, Huihua ; Pan, Jianwei
Abstract:
Gastrointestinal tract involvement in Langerhans cell histiocytosis (LCH) is extremely rare, with limited documentation of endoscopic manifestations. We report a 19‐month‐old girl who presented with repeated diarrhea and bloody stools, accompanied by recurrent pulmonary infections, anemia, hypoproteinemia, thrombocytopenia, coagulopathy, and hepatosplenomegaly with lymphadenopathy. Initial treatment with antibacterial agents, mesalazine, thalidomide, and prednisone led to temporary improvement; however, the symptoms repeatedly relapsed. She underwent three digestive endoscopies, but until the third endoscopy, a definitive diagnosis of Langerhans cell histiocytosis was established through biopsy. While upper gastrointestinal tract findings were not significant, notable changes were observed in the colorectal region. A colonoscopy revealed progression from erythema to diffuse hyperemia and edema, with erythema, erosion, and superficial ulcers extending into the distal ileal mucosa. Genetic analysis identified a BRAF‐V600E mutation. Following treatment with chemotherapy (vincristine and prednisone) and the BRAF inhibitor dabrafenib, the patient demonstrated significant clinical improvement within days. At the 1‐year follow‐up, the patient had normal bowel movements and a weight gain of 2.5 kg. Early gastrointestinal endoscopy with multiple biopsies in suspected children can facilitate early detection. Dabrafenib is a viable treatment option for Langerhans cell histiocytosis.
01 Jan 2025·ARQUIVOS BRASILEIROS DE OFTALMOLOGIA
Choroiditis following severe acute respiratory syndrome coronavirus 2 infection in unvaccinated identical twins
Article
Author: Mello, Luiz Guilherme Marchesi ; Yamamoto, Joyce Hisae ; Hirata, Carlos Eduardo ; Lubiana, Lara Guedes ; Monteiro, Mário Luiz Ribeiro
Unvaccinated identical twins developed bilateral anterior uveitis soon after the onset of coronavirus disease 2019 symptoms. During follow-up, both patients developed choroiditis, and one twine developed posterior scleritis and serous retinal detachment. Prompt treatment with oral prednisone ameliorated the lesions, and no recurrence was observed at the 18-month follow-up. Choroiditis may rarely be associated with severe acute respiratory syndrome coronavirus 2 infection, and it responds well to corticosteroid therapy. Although the exact mechanism is unknown, we hypothesize that the virus may act as an immunological trigger for choroiditis.
595
News (Medical) associated with Prednisone08 Nov 2024
If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage
RARITAN, N.J., Nov. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of a new indication for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in the U.S. and DARZALEX® subcutaneous (SC) formulation in the European Union (EU). The applications are supported by data from the ongoing Phase 3 AQUILA study (NCT03301220) of DARZALEX FASPRO® as monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma.1
Smoldering multiple myeloma is an early precursor of active multiple myeloma, where abnormal cells can be detected in the bone marrow, but patients are typically asymptomatic.2 Fifteen percent of all cases of newly diagnosed multiple myeloma are classified as smoldering multiple myeloma, and half of those diagnosed with high-risk disease will progress to active multiple myeloma within two years.3 Currently, smoldering multiple myeloma is not generally treated until active multiple myeloma develops. Instead, the standard approach is observation to track the disease for signs of biochemical progression and/or end organ damage, when treatment tends to be initiated.2 Recent evidence suggests that those at high-risk for progression to active multiple myeloma could benefit from earlier therapeutic intervention.4
"There remains an unmet need for early interventions and treatments that are both effective and well tolerated in people living with smoldering multiple myeloma at high-risk of progressing to active multiple myeloma," said Yusri Elsayed, M.D., M.H.Sc., Ph.D. Global Therapeutic Area Head, Oncology, Innovative Medicine, Johnson & Johnson. "DARZALEX has changed the standard of care in multiple myeloma, and with these submissions to the FDA and EMA, this therapy could become the first approved treatment for patients with high-risk smoldering multiple myeloma, potentially shifting the treatment paradigm."
The first data from the AQUILA study, evaluating the safety and efficacy of DARZALEX FASPRO® compared to active monitoring in participants with high-risk smoldering multiple myeloma, will be presented at the 2024 American Society of Hematology (ASH) Annual Meeting, taking place in San Diego from December 7-10.4
About the AQUILA Study
AQUILA (NCT03301220) is a randomized, multicenter Phase 3 study investigating DARZALEX FASPRO® versus active monitoring in patients (n=390) with high-risk smoldering multiple myeloma.1 The primary endpoint is progression free survival and secondary endpoints include time to progression, overall response rate and overall survival.1 Patients in the study were diagnosed with smoldering multiple myeloma in the last five years and were excluded if they had prior exposure to approved or investigational treatments for smoldering multiple myeloma or multiple myeloma.1
About Smoldering Multiple Myeloma
Smoldering multiple myeloma is an asymptomatic precursor state to multiple myeloma. Patients with smoldering multiple myeloma have higher levels of abnormal plasma cells in the bone marrow and an elevated monoclonal protein (M-protein) level in the blood, but they do not yet exhibit the symptoms commonly associated with active multiple myeloma, particularly end-organ damage. Fifteen percent of all cases of newly diagnosed multiple myeloma are classified as smoldering multiple myeloma, and half of those diagnosed with high-risk disease will progress to active multiple myeloma within two years.3
About Multiple Myeloma
Multiple myeloma is a blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.5 In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow.6 Multiple myeloma is the second most common blood cancer worldwide and remains an incurable disease.7 In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 will die from the disease.8 People with multiple myeloma have a 5-year survival rate of 59.8 percent.8 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.9,10
About DARZALEX FASPRO® and DARZALEX®
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.11 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.
DARZALEX® (daratumumab) received U.S. FDA approval in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant-eligible and ineligible.12
DARZALEX® is the first CD38-directed antibody approved to treat multiple myeloma.12 DARZALEX®-based regimens have been used in the treatment of more than 518,000 patients worldwide and more than 68,000 patients in the U.S. alone.
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.
For more information, visit .
DARZALEX FASPRO® INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma:
In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant
In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI)
In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
DARZALEX FASPRO® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation.
WARNINGS AND PRECAUTIONS
Hypersensitivity and Other Administration Reactions
Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®.
Systemic Reactions
In a pooled safety population of 1249 patients with multiple myeloma (N=1056) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO® as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 0.7%, Grade 4: 0.1%). Systemic administration-related reactions occurred in 7% of patients with the first injection, 0.2% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 2.9 hours (range: 5 minutes to 3.5 days). Of the 165 systemic administration-related reactions that occurred in 93 patients, 144 (87%) occurred on the day of DARZALEX FASPRO® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.
Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision.
Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO®. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.
Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO®.
Local Reactions
In this pooled safety population, injection-site reactions occurred in 7% of patients, including Grade 2 reactions in 0.8%. The most frequent (>1%) injection-site reaction was injection-site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO®. Monitor for local reactions and consider symptomatic management.
Neutropenia
Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO®, higher rates of Grade 3-4 neutropenia were observed.
Thrombocytopenia
Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO® until recovery of platelets.
Embryo-Fetal Toxicity
Based on the mechanism of action, DARZALEX FASPRO® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO® and for 3 months after the last dose.
The combination of DARZALEX FASPRO® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy.
Interference With Serological Testing
Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted.
Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO®. Type and screen patients prior to starting DARZALEX FASPRO®.
Interference With Determination of Complete Response
Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO®-treated patients with IgG kappa myeloma protein.
ADVERSE REACTIONS
In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema.
The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.
Please
click here
to see the full Prescribing Information for DARZALEX FASPRO®.
DARZALEX® INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
DARZALEX
® (daratumumab) is indicated for the treatment of adult patients with multiple myeloma:
In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor
In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
As monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent
CONTRAINDICATIONS
DARZALEX® is contraindicated in patients with a history of severe hypersensitivity (eg, anaphylactic reactions) to daratumumab or any of the components of the formulation.
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
DARZALEX® can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be lifethreatening, and fatal outcomes have been reported. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37% of patients with the Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX®. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension and blurred vision.
When DARZALEX® dosing was interrupted in the setting of ASCT (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DARZALEX®, the incidence of infusion-related reactions was 11% for the first infusion following ASCT. Infusion-related reactions occurring at re-initiation of DARZALEX® following ASCT were consistent in terms of symptoms and severity (Grade 3 or 4: <1%) with those reported in previous studies at Week 2 or subsequent infusions. In EQUULEUS, patients receiving combination treatment (n=97) were administered the first 16 mg/kg dose at Week 1 split over two days, ie, 8 mg/kg on Day 1 and Day 2, respectively. The incidence of any grade infusion-related reactions was 42%, with 36% of patients experiencing infusion-related reactions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with subsequent infusions.
Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt DARZALEX® infusion for reactions of any severity and institute medical management as needed. Permanently discontinue DARZALEX® therapy if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion.
To reduce the risk of delayed infusion-related reactions, administer oral corticosteroids to all patients following DARZALEX® infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease.
Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®.
Interference With Serological Testing
Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type is not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX®. Type and screen patients prior to starting DARZALEX®.
Neutropenia and Thrombocytopenia
DARZALEX® may increase neutropenia and thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX® until recovery of neutrophils or for recovery of platelets.
Interference With Determination of Complete Response
Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
Embryo-Fetal Toxicity
Based on the mechanism of action, DARZALEX® can cause fetal harm when administered to a pregnant woman. DARZALEX® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX® and for 3 months after the last dose.
The combination of DARZALEX® with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, pomalidomide, or thalidomide prescribing information on use during pregnancy.
ADVERSE REACTIONS
The most frequently reported adverse reactions (incidence ≥20%) were: upper respiratory infection, neutropenia, infusionrelated reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, and asthenia. The most common hematologic laboratory abnormalities (≥40%) with DARZALEX® are: neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia.
Please
click here
to see the full Prescribing Information for DARZALEX®.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.
1 ClinicalTrials.Gov. A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma. Accessed October 2024. Available at: Study Details | A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma | ClinicalTrials.gov
2 Myeloma UK. Smouldering myeloma. Accessed October 2024. Available at: .
3 Rajkumar SV, Kumar S, Lonial S, Mateos MV. Smoldering multiple myeloma current treatment algorithms. Blood Cancer J. 2022 Sep 5;12(9):129.
4 M.A. Dimopoulos, et al. Phase 3 Randomized Study of Daratumumab Monotherapy Versus Active Monitoring in Patients With High-risk Smoldering Multiple Myeloma: Primary Results of the AQUILA Study. Presented at the December 2024 ASH Annual Meeting & Exposition. Abstract JJD-78127.
5 Rajkumar SV. Multiple Myeloma: 2020 Update on Diagnosis, Risk-Stratification and Management. Am J Hematol. 2020;95(5):548-5672020;95(5):548-567.
6 National Cancer Institute. Plasma Cell Neoplasms. Accessed October 2024. Available at:
7 Multiple Myeloma. City of Hope, 2022. Multiple Myeloma: Causes, Symptoms & Treatments. Accessed October 2024. Available at:
8 American Cancer Society. Myeloma Cancer Statistics. Accessed October 2024. Available at:
9 American Cancer Society. What is Multiple Myeloma? Accessed October 2024. Available at:
10 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. Accessed October 2024. Available at:
11 DARZALEX FASPRO® U.S. Prescribing Information
12 DARZALEX® U.S. Prescribing Information
SOURCE Johnson & Johnson
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COPENHAGEN, Denmark--(
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More than 20 abstracts, including four oral presentations, with new clinical data across lines of therapy and subgroups of non-Hodgkin’s lymphoma (NHL) patients
New and updated data from EPCORE
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clinical trial program reinforce the potential of epcoritamab as a monotherapy and in combination to treat multiple B-cell malignancies across lines of therapy
Genmab A/S
(Nasdaq: GMAB)
announced today more than 20 abstracts evaluating epcoritamab-bysp (EPKINLY
®
), a T-cell engaging bispecific antibody administered subcutaneously, across lines of therapy and B-cell non-Hodgkin’s lymphoma (NHL) subtypes, will be presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held at the San Diego Convention Center in San Diego, California, and online, December 7-10.
The breadth of the epcoritamab development program will be featured at this year's ASH in four oral presentations. Three of the oral presentations will highlight data evaluating fixed-duration subcutaneous epcoritamab in patients with previously untreated diffuse large B-cell lymphoma (DLBCL), large B-cell lymphoma (LBCL), and relapsed/refractory (R/R) follicular lymphoma (FL). The fourth oral presentation will feature the results of a study evaluating epcoritamab monotherapy in patients with R/R chronic lymphocytic leukemia (CLL). Additionally, three-year efficacy and safety data for subcutaneous epcoritamab in patients with R/R DLBCL from the EPCORE
®
NHL-1 trial will be presented.
“The data evaluating epcoritamab being presented at this year’s ASH highlight the encouraging clinical results we have seen across epcoritamab clinical trials and demonstrate its potential as a core therapy for B-cell malignancies,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “This has been a pivotal year for epcoritamab, and alongside our partner AbbVie, we are committed to progressing the comprehensive epcoritamab development program with the goal of potentially providing additional therapeutic options to patients in need of treatments.”
All abstracts accepted for presentation have been published on the
ASH Website
.
2024 R&D Update and ASH Data Review
On Wednesday, December 11, at 11:00 AM EST (5:00 PM CET/4:00 PM GMT), Genmab will host its 2024 R&D Update and ASH Data Review. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on
www.genmab.com
. This meeting is not an official program of the ASH Annual Meeting.
Abstracts accepted for presentation at ASH include:
Oral Presentations
Abstract Number
Abstract Title
Type of Presentation
Date/Time of Presentation
342
Fixed-Duration Epcoritamab + R2 Drives Deep and Durable Responses in Patients with Relapsed or Refractory Follicular Lymphoma: 2-Year Follow-Up from Arm 2 of the EPCORE NHL-2 Trial
Oral
Saturday, December 7, 4:00 - 5:30 PM PT
581
Fixed-Duration Epcoritamab + R-CHOP Induces High Complete Response Rates in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma with High-Risk Features: Long-Term Results from the EPCORE NHL-2 Trial
Oral
Sunday, December 8, 12:00 - 1:30 PM PT
867
EPCORE DLBCL-3 First Disclosure: Fixed-Duration Epcoritamab Monotherapy in Older (≥75 y), Anthracycline-Ineligible Patients with Previously Untreated Large B-Cell Lymphoma
Oral
Monday, December 9, 2:45 - 4:15 PM PT
883
Epcoritamab Monotherapy in Patients (Pts) with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from CLL Expansion and Optimization Cohorts of EPCORE CLL-1
Oral
Monday, December 9, 2:45 - 4:15 PM PT
Poster Presentations
Abstract Number
Abstract Title
Type of Presentation
Date/Time of Presentation
1414
Exposure-Response Analyses Supporting Optimal Epcoritamab 48 mg Full Dose and Dosing Schedule in Relapsed or Refractory Follicular Lymphoma
Poster
Saturday, December 7, 5:30 - 7:30 PM PT
1622
Epcoritamab with R-CHOP Overcomes Poor Risk Features of High Metabolic Tumor Volume in High-Risk Large B-Cell Lymphoma
Poster
Saturday, December 7, 5:30 - 7:30 PM PT
1627
Fixed-Duration Epcoritamab in Combination with Bendamustine + Rituximab for First-Line Treatment of Follicular Lymphoma: Initial Results from EPCORE NHL-2 Arm 3
Poster
Saturday, December 7, 5:30 - 7:30 PM PT
1703
Trends in All-Cause Mortality Rates in Patients with Follicular Lymphoma in the US before and during the COVID-19 Pandemic: A Retrospective Observational Study
Poster
Saturday, December 7, 5:30 - 7:30 PM PT
1734
Immune Biomarkers of Mechanism of Action of Epcoritamab (Epcor) Plus Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (pola-R-CHP) in Frontline DLBCL
Poster
Saturday, December 7, 5:30 - 7:30 PM PT
1737
Efficacy and Safety of Epcoritamab Monotherapy in Patients with Relapsed or Refractory LBCL Not Previously Exposed to CAR T: Subanalysis of the EPCORE NHL-1 Trial
Poster
Saturday December 7, 5:30 - 7:30 PM PT
2349
Indirect Comparisons of the Efficacy of Epcoritamab Vs Glofitamab in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)
Poster
Saturday, December 7, 5:30 - 7:30 PM PT
2998
Epcoritamab Induces in vitro-derived Terminally Differentiated Exhausted T Cells to Kill B Cells
Poster
Saturday, December 7, 5:30 - 7:30 PM PT
3106
Fixed-Duration Epcoritamab + R-Mini-CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma Ineligible for Full-Dose R-CHOP: Updated Results from Arm 8 of the EPCORE NHL-2 Trial
Poster
Sunday, December 8, 6:00 - 8:00 PM PT
3110
Fixed-Duration Epcoritamab Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Updated Results from Arm 1 of the Epcore NHL-5 Trial
Poster
Sunday, December 8, 6:00 - 8:00 PM PT
3115
Prior Bendamustine (Benda) Exposure Did Not Impact Clinical Outcomes and Decreased CD4+ but Not CD8+ T-Cells in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Treated with the Bispecific Antibody Epcoritamab (Epcor)
Poster
Sunday, December 8, 6:00 - 8:00 PM PT
3231
T cells from CLL patients on venetoclax mount potent cytotoxic responses in combination with epcoritamab, a CD20/CD3 bispecific antibody.
Poster
Sunday, December 8, 6:00 - 8:00 PM PT
3723
Patient Characteristics and Treatment Patterns for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) By CAR T Eligibility and Treatment Status in France, Germany, Italy, Spain, the UK, and Japan
Poster
Sunday, December 8, 6:00 - 8:00 PM PT
4480
3-Year Update from the EPCORE NHL-1 Trial: Epcoritamab Leads to Deep and Durable Responses in Relapsed or Refractory Large B-Cell Lymphoma
Poster
Monday, December 9, 6:00 - 8:00 PM PT
4491
Three-Factor Prediction Model for Grade 2+Cytokine Release Syndrome in Large B-Cell Lymphoma Patients Receiving Epcoritamab Monotherapy
Poster
Monday, December 9, 6:00 - 8:00 PM PT
5124
Epcoritamab for Relapsed/ Refractory B cell Lymphoma – the Israeli Real-World Experience
Poster
Monday, December 9, 6:00 - 8:00 PM PT
E-publications
Abstract Number
Abstract Title
Type of Presentation
Date/Time of Presentation
7614
Cost-Effectiveness of Epcoritamab Versus Glofitamab in Relapsed or Refractory Large B-Cell Lymphoma after at Least Two Lines of Therapy in the United States
E-publication
N/A
7617
A Canadian Cost-Utility Analysis of Epcoritamab Versus Current Therapies in Third-Line or Later Large B-Cell Lymphoma
E-publication
N/A
7757
Epcoritamab plus Gemcitabine and Oxaliplatin versus Glofitamab or Rituximab plus Gemcitabine and Oxaliplatin in Transplant-Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients: A Match-Adjusted Comparative Analysis
E-publication
N/A
7760
Epcoritamab plus Gemcitabine and Oxaliplatin versus Rituximab, Gemcitabine, and Oxaliplatin in Transplant-Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients: A Match-Adjusted Comparative Analysis
E-publication
N/A
7802
Matching-Adjusted Indirect Treatment Comparison of Epcoritamab versus Zanubrutinib Plus Obinutuzumab in Relapsed or Refractory Follicular Lymphoma
E-publication
N/A
The safety and efficacy of epcoritamab has not been established for these investigational uses.
About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody
®
technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.
i
Epcoritamab (approved under the brand name EPKINLY
®
in the U.S. and Japan, and TEPKINLY
®
in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.
Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (
NCT04628494
), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (
NCT05578976
), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (
NCT05409066
), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (
NCT06191744
). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit
www.clinicaltrials.gov
for more information.
EPKINLY
®
(epcoritamab-bysp) U.S. IMPORTANT SAFETY INFORMATION
Important Warnings—EPKINLY can cause serious side effects, including:
Cytokine release syndrome (CRS)
, which is common during treatment with EPKINLY and can be serious or life-threatening. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
Neurologic problems
that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.
People with DLBCL or high-grade B-cell lymphoma
should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic problems.
Tell your healthcare provider or get medical help right away
if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss.
These may be symptoms of CRS or neurologic problems.
If you have any symptoms that impair consciousness,
do not
drive or use heavy machinery or do other dangerous activities until your symptoms go away.
EPKINLY can cause other serious side effects, including:
Infections
that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell.
Low blood cell counts,
which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.
Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.
Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you
have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby.
If you are a female who can become pregnant
, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.
In DLBCL or high-grade B-cell lymphoma, the most common side effects of EPKINLY
include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea.
The most common severe abnormal laboratory test results
include decreased white blood cells, decreased red blood cells, and decreased platelets.
In follicular lymphoma the most common side effects of EPKINLY
include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache.
The most common severe abnormal laboratory test results
include decreased white blood cells and decreased red blood cells.
These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or
www.fda.gov/medwatch
or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).
Please see
Medication Guide
, including Important Warnings.
About Genmab
Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO
®
) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit
Genmab.com
and follow us on
LinkedIn
and
X
.
This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on
www.genmab.com
and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings
with the U.S. Securities and Exchange Commission (SEC), which are available at
www.sec.gov
. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab
®
; the Y-shaped Genmab logo
®
; Genmab in combination with the Y-shaped Genmab logo
®
; HuMax
®
; DuoBody
®
; HexaBody
®
; DuoHexaBody
®
, HexElect
®
and KYSO™.
_______________________________
i
Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing.
EBioMedicine
. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625.
ImmunotherapyPhase 3Drug ApprovalASHClinical Result
05 Nov 2024
SOUTH SAN FRANCISCO, Calif.--(
BUSINESS WIRE
)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present more than 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 7-10, 2024 in San Diego, California. The data underscore Genentech’s commitment to advance patient outcomes in lymphoma with long-term follow-up of its approved medicines Polivy
®
(polatuzumab vedotin-piiq), Lunsumio
®
(mosunetuzumab-axgb) and Columvi
®
(glofitamab-gxbm) as well as new investigational combination data.
Key presentations include:
Five-year data from the Phase III POLARIX study (abstract #469) reinforce the potential of Polivy in combination with Rituxan
®
(rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to provide durable and lasting remissions and for the first time show a positive trend in overall survival (OS) for people with first-line diffuse large B-cell lymphoma (DLBCL), an area that previously had little advancement in nearly two decades.
Extended follow-up data of up to four years from the pivotal GO29781 study of Lunsumio (abstract #4407) and NP30179 study of Columvi (abstract #865) show long-lasting remissions and immune system recovery after the end of treatment, supporting the use of fixed-duration bispecific antibodies for third-line or later (3L+) follicular lymphoma (FL) and DLBCL, respectively.
First presentation of data for a subcutaneous formulation of Lunsumio monotherapy from the pivotal Phase II GO29781 study (abstract #1645) show high rates of deep and durable responses and low rates and severity of cytokine release syndrome in people with 3L+ FL. Subcutaneously administered Lunsumio could further improve the patient experience by combining shorter administration time with the existing benefits of a fixed-duration and outpatient therapy.
New patient-reported outcomes data from the Phase III STARGLO study (abstract #5132) indicate comparable health-related quality of life between treatment arms, despite higher median number of cycles received with the Columvi combination (11 versus 4). Together with the significant improvement in OS observed in the study, these data support the potential benefit for patients with second-line or later DLBCL.
New and updated data from investigational study combinations of Polivy with bispecific antibodies Lunsumio and Columvi in relapsed or refractory DLBCL, including the Phase Ib/II NP39488 (abstract #988) and Phase II GO40516 (abstract #989) studies, add to the growing body of evidence demonstrating the potential of novel bispecific antibody/Polivy combinations in earlier treatment lines, and support their ongoing Phase III development.
Overview of key presentations featuring Genentech medicines
Medicine
Abstract title
Abstract number/presentation details
Polivy
Five-Year Analysis of the POLARIX Study: Prolonged Follow-up Confirms Positive Impact of Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) on Outcomes
#469 oral presentation
Session: 626. Aggressive Lymphomas: Clinical and Epidemiological: CARs, Bispecifics, and ADCs: Progress and Challenges in Aggressive B Cell Lymphoma
Sunday, December 8, 2024
9:30 AM PST
A Multicenter, Prospective, Observational Study of Pola-R-CHP in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (POLASTAR): A Preliminary Analysis
#4475 poster presentation
Session: 626. Aggressive Lymphomas: Clinical and Epidemiological: Poster III
Monday, December 9, 2024
6:00 - 8:00 PM PST
Lunsumio
A Randomized Phase II Study of Mosunetuzumab SC Plus Polatuzumab Vedotin Demonstrates Improved Outcomes Versus Rituximab Plus Polatuzumab Vedotin in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)
#989 oral presentation
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: Chemotherapy-free Combinations for Relapsed Aggressive Lymphomas
Monday, December 9, 2024
5:30 PM PST
Subcutaneous Mosunetuzumab Leads to High Rates of Durable Responses, Low Rates of Cytokine Release Syndrome, and Non-Inferior Exposure Compared with Intravenous Administration in Patients with Relapsed/Refractory Follicular Lymphoma: Primary Analysis of a Pivotal Phase II Study
#1645 poster presentation
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Saturday, December 7, 2024
5:30 - 7:30 PM PST
Mosunetuzumab Continues to Demonstrate Clinically Meaningful Outcomes in Patients with Relapsed and/or Refractory Follicular Lymphoma after ≥2 Prior Therapies Including Those with a History of POD24: 4-Year Follow-up of a Pivotal Phase II Study
#4407 poster presentation
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Monday, December 9, 2024
6:00 - 8:00 PM PST
Mosunetuzumab Monotherapy Demonstrates Encouraging Activity and a Manageable Safety Profile in Patients with Heavily Pre-Treated Relapsed or Refractory Mantle Cell Lymphoma
#1646 poster presentation
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Saturday, December 7, 2024
5:30 - 7:30 PM PST
Fixed-Duration Subcutaneous Mosunetuzumab is Active and has a Manageable Safety Profile in Patients with Previously Untreated, Low-Tumor Burden Follicular Lymphoma: Updated Results from the Phase II MorningSun Study
#3008 poster presentation
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II
Sunday, December 8, 2024
6:00 - 8:00 PM PST
Travel Burden and Travel Costs of Bispecific Antibodies in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Relapsed/Refractory Follicular Lymphoma
#782 oral presentation
Session: 902. Health Services and Quality Improvement: Lymphoid Malignancies: For a Better Tomorrow - Improving Access to Blood Cancer Treatments and Trials
Monday, December 9, 2024
10:45 AM PST
Columvi
Fixed-duration Glofitamab Monotherapy Continues to Demonstrate Durable Responses in Patients with Relapsed or Refractory Large B-Cell Lymphoma: 3-year Follow-Up From a Pivotal Phase II Study
#865 oral presentation
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: New R-CHOP Combinations for Treatment Naïve DLBCL
Sunday, December 8, 2024
Midday PST
Glofitamab in Combination with Polatuzumab Vedotin Maintains Durable Responses and a Manageable Safety Profile in Patients with Heavily Pre-treated Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Including High-Grade B-Cell Lymphoma (HGBCL): Extended Follow-Up of a Phase Ib/II Study
#988 oral presentation
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: Chemotherapy-free Combinations for Relapsed Aggressive Lymphomas
Monday, December 9, 2024
5:15 PM PST
Glofitamab in Combination with Rituximab plus Ifosfamide, Carboplatin, and Etoposide shows Favorable Efficacy and Manageable Safety in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma, Eligible for Stem Cell Transplant or Chimeric Antigen Receptor T-cell Therapy: Results from a Phase Ib Study
#987 oral presentation
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: Chemotherapy-free Combinations for Relapsed Aggressive Lymphomas
Monday, December 9, 2024
5:00 PM PST
Primary Results of Patient-Reported Outcomes in Patients with Relapsed/Refractory Diffuse Large
B-cell Lymphoma Treated with Glofitamab plus Gemcitabine and Oxaliplatin (Glofit-GemOx) Versus Rituximab plus GemOx (R-GemOx) from the Phase III STARGLO Study
#5132 poster presentation
Session: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster III
Monday, December 9, 2024
6:00 - 8:00 PM PST
Glofitamab Induces High Response Rates and Durable Remissions in Patients (Pts) with Heavily Pretreated Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL), including those with a Poor Prognosis: Subgroup Results from a Phase I/II Study
#1631 poster presentation
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Saturday, December 7, 2024
5:30 - 7:30 PM PST
A Healthcare Utilization Model Comparing Time Toxicity Between Glofitamab and Epcoritamab Treatment Regimens
#3647 poster presentation
Session: 902. Health Services and Quality Improvement: Lymphoid Malignancies: Poster II
Sunday, December 8, 2024
6:00 - 8:00 PM PST
Englumafusp alfa
Englumafusp Alfa (CD19-4-1BBL) Combined with Glofitamab is Safe and Efficacious in Patients with R/R B-NHL: Extended Follow Up Analysis of the Dose-Escalation Part of Phase I Trial BP41072
#990 oral presentation
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: Chemotherapy-free Combinations for Relapsed Aggressive Lymphomas
Monday, December 9, 2024
5:45 PM PST
Cevostamab
Cevostamab in Patients with Heavily Pretreated Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from an Ongoing Phase I Study Demonstrate Clinically Meaningful Activity and Manageable Safety and Inform the Doses and Regimen for Combination Studies
#1021 oral presentation
Session: 654. Multiple Myeloma: Pharmacologic Therapies: Into the Future: New Drugs and Combinations in Multiple Myeloma
Monday, December 9, 2024
4:30 PM PST
Venclexta
®
(venetoclax)*
CRISTALLO: Results from a Phase III Trial of Venetoclax–Obinutuzumab versus Fludarabine, Cyclophosphamide and Rituximab or Bendamustine–Rituximab in Patients with Untreated Chronic Lymphocytic Leukemia Without Del(17p) or TP53 Mutations
#3237 poster presentation
Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II
Sunday, December 8, 2024
6:00 - 8:00 PM PST
P-CD19CD20-ALLO1
(in collaboration with Poseida Therapeutics)
P-CD19CD20-ALLO1: Potent Fully Allogeneic CAR-T Therapy Targeting CD19 and CD20 with Superior Efficacy Over Single-Target Products
#4805 poster presentation
Session: 702. CAR-T Cell Therapies: Basic and Translational: Poster III
Monday, December 9, 2024
6:00 - 8:00 PM PST
P-BCMA-ALLO1 (in collaboration with Poseida Therapeutics)
A Phase 1 Study of P-BCMA-ALLO1, a Non-viral, Allogeneic BCMA Directed CAR-T in Relapsed/Refractory Multiple Myeloma (RRMM): Results from Optimized Lymphodepletion Cohort
#4828 poster presentation
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
Monday, December 9, 2024
6:00 - 8:00 PM PST
Hemlibra
®
(emicizumab)
Bleed Patterns in Infants, From Birth to 12 Months of Age, with Hemophilia A Treated with Emicizumab: Exploratory Analysis of the HAVEN 7 Study
#1214 poster presentation
Session: 322. Hemophilia A and B: Clinical and Epidemiological: Poster I
Saturday, December 7, 2024
5:30 - 7:30 PM PST
Real-World Experience With Emicizumab for Hemophilia A From the Physician Perspective Based on Survey Data
#5078 poster presentation
Session: 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster III
Monday, December 9, 2024
6:00 - 8:00 PM PST
PiaSky
®
(crovalimab)
Phase III Randomized COMMODORE 2 Trial: 2-Year Efficacy and Safety of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Naive to Complement Inhibition
#2687 poster presentation
Session: 508. Bone Marrow Failure: Acquired: Poster II
Sunday, December 8, 2024
6:00 - 8:00 PM PST
Phase III COMMODORE 1 Trial: 2-Year Efficacy and Safety of Crovalimab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Switched from Ravulizumab
#4078 poster presentation
Session: 508. Bone Marrow Failure: Acquired: Poster III
Monday, December 9, 2024
6:00 - 8:00 PM PST
*Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.
About Polivy
®
(polatuzumab vedotin-piiq)
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL.
Polivy U.S. Indication
Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL).
Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies.
Important Safety Information
Possible serious side effects
Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are.
Some people who have been treated with Polivy have experienced serious to fatal side effects.
Your doctor may stop or adjust your treatment if any serious side effects occur.
Be sure to contact your healthcare team if there are any signs of these side effects.
Nerve problems in your arms and legs:
This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
Infusion-related reactions:
You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
Low blood cell counts:
Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy
Infections:
If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections
Rare and serious brain infections:
Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
Tumor lysis syndrome:
Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver:
Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication
Side effects seen most often
The most common side effects during treatment were
Nerve problems in arms and legs
Nausea
Tiredness or lack of energy
Diarrhea
Constipation
Hair loss
Redness and sores of the lining of the mouth, lips, throat, and digestive tract
Polivy may lower your red or white blood cell counts and increase uric acid levels.
Polivy may not be for everyone. Talk to your doctor if you are
Pregnant or think you are pregnant:
Data have shown that Polivy may harm your unborn baby
Planning to become pregnant:
Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment
Breastfeeding:
Women should not breastfeed while taking Polivy and for 2 months after the last dose
These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment.
You may report side effects to the FDA at (800) FDA-1088 or
http://www.fda.gov/medwatch
. You may also report side effects to Genentech at (888) 835-2555.
Please see the
full Prescribing Information
and visit
https://www.Polivy.com
for additional Important Safety Information.
About Lunsumio
®
(mosunetuzumab-axgb)
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin’s lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.
Lunsumio U.S. Indication
Lunsumio (mosunetuzumab-axgb) is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer.
It is not known if Lunsumio is safe and effective in children.
The conditional approval of Lunsumio is based on response rate. There are ongoing studies to establish how well the drug works.
What is the most important information I should know about Lunsumio?
Lunsumio may cause Cytokine Release Syndrome (CRS),
a serious side effect that is common during treatment with Lunsumio and can also be severe or life-threatening.
Get medical help right away if you develop any signs or symptoms of CRS at any time, including:
fever of 100.4°F (38°C) or higher
chills
low blood pressure
fast or irregular heartbeat
tiredness or weakness
difficulty breathing
headache
confusion
feeling anxious
dizziness or light-headedness
nausea
vomiting
Due to the risk of CRS, you will receive Lunsumio on a “step-up dosing schedule.”
The step-up dosing schedule is when you receive smaller “step-up” doses of Lunsumio on Day 1 and Day 8 of your first cycle of treatment
You will receive a higher dose of Lunsumio on Day 15 of your first cycle of treatment
If your dose of Lunsumio is delayed for any reason, you may need to repeat the step-up dosing schedule
Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS
Your healthcare provider will check you for CRS during treatment with Lunsumio and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Lunsumio, if you have severe side effects.
What are the possible side effects of Lunsumio?
Lunsumio may cause serious side effects, including:
Neurologic problems.
Your healthcare provider will check you for neurologic problems during treatment with Lunsumio. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with Lunsumio, including:
headache
numbness and tingling of the arms, legs, hands, or feet
dizziness
confusion and disorientation
difficulty paying attention or understanding things
forgetting things or forgetting who or where you are
trouble speaking, reading, or writing
sleepiness or trouble sleeping
tremors
loss of consciousness
seizures
muscle problems or muscle weakness
loss of balance or trouble walking
Serious infections.
Lunsumio can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with Lunsumio, including:
fever of 100.4° F (38° C) or higher
chest pain
tiredness
shortness of breath
painful rash
sore throat
pain during urination
feeling weak or generally unwell
Low blood cell counts.
Low blood cell counts are common during treatment with Lunsumio and can also be severe. Your healthcare provider will check your blood cell counts during treatment with Lunsumio. Lunsumio may cause the following low blood cell counts:
low white blood cell counts (neutropenia).
Low white blood cells can increase your risk for infection
low red blood cell counts (anemia).
Low red blood cells can cause tiredness and shortness of breath
low platelet counts (thrombocytopenia).
Low platelet counts can cause bruising or bleeding problems
Growth in your tumor or worsening of tumor related problems (Tumor flare).
Lunsumio may cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with Lunsumio: tender or swollen lymph nodes, chest pain, cough, trouble breathing, and pain or swelling at the site of the tumor
Your healthcare provider may temporarily stop or permanently stop treatment with Lunsumio if you develop severe side effects.
The most common side effects of Lunsumio include:
tiredness, rash, fever, and headache.
The most common severe abnormal lab test results with Lunsumio include:
decreased phosphate, increased glucose, and increased uric acid levels.
Before receiving Lunsumio, tell your healthcare provider about all of your medical conditions, including if you:
have ever had an infusion reaction after receiving Lunsumio
have an infection, or have had an infection in the past which lasted a long time or keeps coming back
have or have had Epstein-Barr Virus
are pregnant or plan to become pregnant. Lunsumio may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Lunsumio
Females who are able to become pregnant:
your healthcare provider should do a pregnancy test before you start treatment with Lunsumio
you should use an effective method of birth control during your treatment and for 3 months after the last dose of Lunsumio
are breastfeeding or plan to breastfeed. It is not known if Lunsumio passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of Lunsumio
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while receiving Lunsumio?
Do not
drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.
These are not all the possible side effects of Lunsumio. Talk to your healthcare provider for more information about the benefits and risks of Lunsumio.
You may report side effects to the FDA at (800) FDA-1088 or
http://www.fda.gov/medwatch
. You may also report side effects to Genentech at (888) 835-2555.
Please see Important Safety Information, including Serious Side Effects, as well as the Lunsumio full
Prescribing Information
and
Medication Guide
or visit
https://www.Lunsumio.com
.
About Columvi
®
(glofitamab-gxbm)
Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. A clinical development program for Columvi is ongoing, investigating the molecule as a monotherapy and in combination with other medicines for the treatment of people with B-cell non-Hodgkin’s lymphomas, including diffuse large B-cell lymphoma and other blood cancers.
Columvi U.S. Indication
Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer.
It is not known if Columvi is safe and effective in children.
The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.
What is the most important information I should know about Columvi?
Columvi can cause Cytokine Release Syndrome (CRS),
a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death.
Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including:
fever of 100.4°F (38°C) or higher
chills or shaking
fast or irregular heartbeat
dizziness or light-headedness
trouble breathing
shortness of breath
Due to the risk of CRS, you will receive Columvi on a “step-up dosing schedule”.
A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1).
You will start the Columvi step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller “step-up” doses of Columvi on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose.
You will receive your first full dose of Columvi a week after the second step-up dose (this will be Day 1 of Cycle 2).
If your dose of Columvi is delayed for any reason, you may need to repeat the “step-up dosing schedule”.
If you had more than mild CRS with your previous dose of Columvi, you should be hospitalized during and for 24 hours after receiving your next dose of Columvi.
Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions.
Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects.
Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers.
The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away.
What are the possible side effects of Columvi?
Columvi may cause serious side effects, including:
Cytokine Release Syndrome.
Neurologic problems.
Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including:
headache
confusion and disorientation
difficulty paying attention or understanding things
trouble speaking
sleepiness
memory problems
numbness, tingling, or weakness of the hands or feet
dizziness
shaking (tremors)
Serious Infections.
Columvi can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat.
Growth in your tumor or worsening of tumor related problems (tumor flare).
Tell your healthcare provider if you get any of these signs or symptoms of tumor flare:
tender or swollen lymph nodes
pain or swelling at the site of the tumor
chest pain
cough
trouble breathing
The most common side effects of Columvi include:
CRS, muscle and bone pain, rash, and tiredness.
The most common severe abnormal lab test results with Columvi include:
decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).
Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects.
Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you:
have an infection
have kidney problems
are pregnant or plan to become pregnant. Columvi may harm your unborn baby
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with Columvi.
You should use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi.
are breastfeeding or plan to breastfeed. Columvi may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while receiving Columvi?
Do not
drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.
These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi.
You may report side effects to the FDA at (800) FDA-1088 or
http://www.fda.gov/medwatch
. You may also report side effects to Genentech at (888) 835-2555.
Please see Important Safety Information, including
Serious Side Effects
, as well as the Columvi full
Prescribing Information
and
Medication Guide
or visit
https://www.Columvi.com
.
About Venclexta
®
(venetoclax)
Venclexta is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood cancers.
Venclexta U.S. Indications
Venclexta is a prescription medicine used:
to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
‒ are 75 years of age or older, or
‒ have other medical conditions that prevent the use of standard chemotherapy.
It is not known if Venclexta is safe and effective in children.
Important Safety Information
What is the most important information patients should know about Venclexta?
Venclexta can cause serious side effects, including:
Tumor lysis syndrome (TLS).
TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. The patient’s doctor will do tests to check their risk of getting TLS before they start taking Venclexta. The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS. The patient may also need to receive intravenous (IV) fluids into their vein.
The patient’s doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta. It is important for patients to keep appointments for blood tests. Patients should tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.
Patients should drink plenty of water during treatment with Venclexta to help reduce the risk of getting TLS.
Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before the first dose on the day of the first dose of Venclexta, and each time a dose is increased.
The patient’s doctor may delay, decrease the dose, or stop treatment with Venclexta if the patient has side effects. When restarting Venclexta after stopping for 1 week or longer, the patient’s doctor may again check for the risk of TLS and change the patient’s dose.
What patients should not take Venclexta?
Certain medicines must not be taken when the patient first starts taking Venclexta and while the dose is being slowly increased because of the risk of increased TLS.
Patients should tell their doctor about all the medicines they take,
including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venclexta and other medicines may affect each other causing serious side effects.
Patients must not start new medicines during treatment with Venclexta without first talking with their doctor.
Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they:
Have kidney or liver problems.
Have problems with body salts or electrolytes, such as potassium, phosphorus, or calcium.
Have a history of high uric acid levels in the blood or gout.
Are scheduled to receive a vaccine. Patients should not receive a “live vaccine” before, during, or after treatment with Venclexta, until the patient’s doctor tells them it is okay. If the patient is not sure about the type of immunization or vaccine, the patient should ask their doctor. These vaccines may not be safe or may not work as well during treatment with Venclexta.
Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If the patient is able to become pregnant, the patient’s doctor should do a pregnancy test before the patient starts treatment with Venclexta, and the patient should use effective birth control during treatment and for at least 30 days after the last dose of Venclexta. If the patient becomes pregnant or thinks they are pregnant, the patient should tell their doctor right away.
Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into the patient’s breast milk. Patients are instructed to not breastfeed during treatment with Venclexta and for 1 week after the last dose.
What to avoid while taking Venclexta:
Patients should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient’s blood.
What are the possible side effects of Venclexta?
Venclexta can cause serious side effects, including:
Low white blood cell counts (neutropenia).
Low white blood cell counts are common with Venclexta, but can also be severe. The patient’s doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing.
Infections.
Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with Venclexta. The patient’s doctor will closely monitor and treat the patient right away if they have a fever or any signs of infection during treatment with Venclexta.
Patients should tell their doctor right away if they have a fever or any signs of an infection during treatment with Venclexta.
The most common side effects of Venclexta when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include
low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of arms, legs, hands, and feet.
The most common side effects of Venclexta in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include
nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.
Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility.
These are not all the possible side effects of Venclexta. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at 1-800-FDA-1088
or
http://www.fda.gov/medwatch
. Report side effects to Genentech at 1-888-835-2555.
Please see the Venclexta full
Prescribing Information
, including the
Medication Guide
, for additional Important Safety Information or visit
https://www.venclexta.com/
.
About Hemlibra
Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins required to activate the natural coagulation cascade and restore the blood clotting process for hemophilia A patients. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once weekly, every two weeks or every four weeks. Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech
.
Hemlibra U.S. Indication
Hemlibra is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A with or without factor VIII inhibitors.
Important Safety Information
What is the most important information to know about Hemlibra?
Hemlibra increases the potential for blood to clot. People who use activated prothrombin complex concentrate (aPCC; Feiba
®
) to treat breakthrough bleeds while taking Hemlibra may be at risk of serious side effects related to blood clots.
These serious side effects include:
Thrombotic microangiopathy (TMA),
a condition involving blood clots and injury to small blood vessels that may cause harm to one’s kidneys, brain, and other organs
Blood clots (thrombotic events),
which may form in blood vessels in the arm, leg, lung, or head
Patients should talk to their doctor about the signs and symptoms of these serious side effects, which can include
Confusion
Stomach, chest, or back pain
Weakness
Nausea or vomiting
Swelling, pain, or redness
Feeling sick or faint
Decreased urination
Swelling of arms and legs
Yellowing of skin and eyes
Eye pain, swelling, or trouble seeing
Fast heart rate
Numbness in your face
Headache
Shortness of breath
Coughing up blood
If patients experience any of these symptoms during or after treatment with Hemlibra, they should get medical help right away.
Patients should carefully follow their healthcare provider’s instructions regarding when to use an on demand bypassing agent or factor VIII, and the dose and schedule to use for breakthrough bleed treatment. If aPCC (Feiba
®
) is needed, patients should talk to their healthcare provider in case they feel they need more than 100 U/kg of aPCC (Feiba
®
) total.
Patients’ bodies may make antibodies against Hemlibra, which may stop Hemlibra from working properly. Patients should contact their healthcare provider immediately if they notice that Hemlibra has stopped working for them (e.g., increase in bleeds).
The most common side effects of Hemlibra include:
injection site reactions (redness, tenderness, warmth, or itching at the site of injection), headache, and joint pain. These are not all of the possible side effects of Hemlibra. Patients can speak with their healthcare provider for more information.
What else should patients know about Hemlibra?
Patients should see the detailed “Instructions for Use” that comes with Hemlibra for information on how to prepare and inject a dose of Hemlibra, and how to properly throw away (dispose of) used needles and syringes.
Patients should stop taking their prophylactic bypassing therapy the day before they start Hemlibra
Patients may continue taking their prophylactic factor VIII for the first week of Hemlibra
Hemlibra may interfere with laboratory tests that measure how well blood is clotting and create an inaccurate result. Patients should speak with their healthcare provider about how this may affect their care.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Patients should only use Hemlibra for the condition it was prescribed. Patients should not give Hemlibra to other people, even if they have the same symptoms that they have. It may harm them.
Patients should tell their healthcare provider about all the medicines they take
, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements. Patients should keep a list of them to show their healthcare provider and pharmacist.
Before using Hemlibra, patients should tell their healthcare provider about all of their medical conditions
, including if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.
Since Hemlibra was tested in males, there is no information on whether Hemlibra may impact an unborn baby or breast milk. Females who are able to become pregnant should use birth control during treatment.
Side effects may be reported to the FDA at (800) FDA-1088 or
www.fda.gov/medwatch
. Side effects may also be reported to Genentech at (888) 835-2555.
Please see Important Safety Information, including Serious Side Effects, as well as the Hemlibra full
Prescribing Information
and
Medication Guide
or visit
https://www.hemlibra.com/
.
Indications & Important Safety Information
What is PIASKY?
PIASKY is a prescription medicine used to treat a disease called paroxysmal nocturnal hemoglobinuria (PNH) in adults and children 13 years of age or older who weigh at least 88 pounds (40 kg).
It is not known if PIASKY is safe and effective in children under 13 years of age and in people who weigh less than 88 pounds (40kg).
What is the most important information I should know about PIASKY?
PIASKY is a medicine that can affect your immune system. PIASKY may lower the ability of your immune system to fight infections
PIASKY increases your chance of getting serious infections caused by
Neisseria meningitidis
. Meningococcal infections may quickly become life-threatening or cause death if not recognized and treated early.
You must complete or update your meningococcal vaccines at least 2 weeks before your first dose of PIASKY.
If your healthcare provider decides that immediate treatment with PIASKY is needed and your meningococcal vaccination is not up to date, you should receive meningococcal vaccination as soon as possible, and receive antibiotics for as long as your healthcare provider tells you.
If you have been given a meningococcal vaccine in the past, you might need additional vaccines before starting PIASKY. Your healthcare provider will decide if you need additional meningococcal vaccine.
Meningococcal vaccines do not prevent all meningococcal infections.
Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection:
fever
fever and a rash
fever with a high heart rate
fever with a headache
headache with nausea or vomiting
headache with a stiff neck or stiff back
confusion
muscle aches, with flu-like symptoms
eyes sensitive to light
Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection.
Carry it with you at all times during treatment and for 11 months after your last dose of PIASKY. Your risk of meningococcal infection may continue for several months after your last dose of PIASKY. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.
PIASKY is only available through a program called the PIASKY Risk Evaluation and Mitigation Strategy (PIASKY REMS). Before you can receive PIASKY, your healthcare provider must:
enroll in the PIASKY REMS program.
counsel you about the risk of serious meningococcal infection.
give you information about the signs and symptoms of serious meningococcal infection.
make sure that you are vaccinated with a meningococcal vaccine and that you receive antibiotics if you need to start PIASKY right away if you are not up to date on your vaccines.
give you a Patient Safety Card about your risk of meningococcal infection.
Immune system reactions
called Type III hypersensitivity reactions are common during treatment with PIASKY and can be serious. If you are currently being treated with or have been treated with another C5 inhibitor medicine
and you switch to PIASKY
, PIASKY may cause Type III hypersensitivity reactions. People may also develop Type III hypersensitivity reactions when they switch from PIASKY to another C5 inhibitor medicine.
If you have been treated with another C5 inhibitor medicine and you switch to PIASKY, or if you have been treated with PIASKY and you switch to another C5 inhibitor medicine, your healthcare provider should monitor you for 30 days after you switch medicines.
Call your healthcare provider or go to the nearest emergency room right away if you have any signs or symptoms of Type III hypersensitivity reaction including:
joint pain
muscle or bone pain
rash or skin problems
itching
headache
kidney problems
numbness and tingling or a feeling of pins and needles especially of the hands and feet
fever
weakness, tiredness, or lack of energy
stomach trouble or pain
PIASKY may also increase the risk of other types of serious infections
, including infections caused by
Neisseria spp.
,
Streptococcus pneumoniae
,
Haemophilus influenzae
, and
Neisseria gonorrhoeae
.
If you receive treatment with PIASKY, you should receive vaccines against
Streptococcus pneumoniae
.
If your child receives treatment with PIASKY, your child should receive vaccines against
Streptococcus pneumoniae
and may receive vaccines against
Haemophilus influenzae
, depending on their age.
Call your healthcare provider right away if you have any new signs or symptoms of infection such as:
fever of 100.4°F (38°C) or higher
cough
chest pain
tiredness
feeling short of breath
painful rash
sore throat
burning pain when passing urine
feeling weak or generally unwell
Who should not receive PIASKY?
Do not receive PIASKY if you:
Have a serious meningococcal infection caused by
Neisseria meningitidis
when you are starting PIASKY treatment.
Are allergic to crovalimab or any of the ingredients in PIASKY.
Before receiving PIASKY tell your healthcare provider about all of your medical conditions, including if you:
have an infection or fever.
are pregnant or plan to become pregnant. It is not known if PIASKY may harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if PIASKY passes into your breast milk.
Tell your healthcare provider about all the medicines you take
, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PIASKY and other medicines can affect each other, causing side effects.
Especially tell your healthcare provider
if you are currently being treated with or have ever been treated with any other complementary C5 inhibitor (C5 inhibitor) medicine. PIASKY is a C5 inhibitor medicine. Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I receive PIASKY?
Your healthcare provider will give you your PIASKY treatment.
Your first dose will be given through a vein by intravenous (IV) infusion on Day 1 by your healthcare provider. This is the first loading dose.
Another loading dose will be given as an injection under the skin (subcutaneous) on Days 2, 8, 15, and 22.
Your maintenance doses will begin on Day 29 and then will be given every 4 weeks as a subcutaneous injection.
Your healthcare provider will prescribe the dose based on your weight. If your weight changes, tell your healthcare provider.
Talk to your healthcare provider if you miss receiving your dose of PIASKY.
If you are changing treatment from another C5 inhibitor such as eculizumab or ravulizumab to PIASKY
, you should receive your first loading dose of PIASKY no sooner than the time you would have received your next scheduled dose of eculizumab or ravulizumab.
If you stop taking PIASKY
and do not switch to another treatment for your PNH, your healthcare provider will need to monitor you closely for at least 20 weeks after stopping PIASKY.
Stopping treatment with PIASKY may cause a breakdown of red blood cells due to PNH.
Symptoms or problems that can happen due to red blood cell breakdown include:
a lower number of red blood cells (anemia)
blood in your urine or dark urine
feeling short of breath
feeling tired or low energy (fatigue)
stomach pain
blood clotting (thrombosis)
difficulty swallowing
difficulty getting or keeping an erection (erectile dysfunction)
kidneys not working properly
What are the possible side effects of PIASKY?
PIASKY can cause serious side effects including:
Infusion- and injection-related reactions.
Infusion- or injection-related reactions may happen during or after your PIASKY administration. Symptoms may include headache, pain at infusion or injection site or in other parts of your body, swelling, bruising or bleeding, red skin, itching and rash.
PIASKY can also cause serious allergic reactions.
Tell your healthcare provider right away or go to the nearest emergency room if you get any of the following symptoms or symptoms of a serious allergic reaction:
shortness of breath or trouble breathing
pain or tightness in your chest
wheezing
feeling dizzy or lightheaded
swelling of the throat, lips, tongue, or face
skin itching, hives, or rash
fever or chills
The most common side effects of PIASKY are:
infusion-related reactions
respiratory tract infections including infections of the lungs, cold symptoms, and pain or swelling of the nose or throat
viral infections
Type III hypersensitivity reactions
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the possible side effects of PIASKY. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
. You may also report side effects to Genentech at (888) 835-2555.
Please see the full
Prescribing Information
and
Medication Guide
for additional Important Safety Information, including
Serious Side Effects
, or visit
https://www.piasky.com/
.
About Genentech in Hematology
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit
http://www.gene.com/hematology
.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit
http://www.gene.com
.
Phase 2Clinical ResultPhase 3Phase 1ASH
100 Deals associated with Prednisone
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D00473 | Prednisone |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Adrenal Hyperplasia, Congenital | US | 26 Jul 2012 | |
| Adrenal Insufficiency | US | 26 Jul 2012 | |
| Alveolitis, Extrinsic Allergic | US | 26 Jul 2012 | |
| Anemia, Diamond-Blackfan | US | 26 Jul 2012 | |
| Anemia, Hemolytic | US | 26 Jul 2012 | |
| Ankylosing Spondylitis | US | 26 Jul 2012 | |
| Arthritis, Psoriatic | US | 26 Jul 2012 | |
| Aspergillosis, Allergic Bronchopulmonary | US | 26 Jul 2012 | |
| Asthma | US | 26 Jul 2012 | |
| Brain Edema | US | 26 Jul 2012 | |
| Bronchiolitis Obliterans | US | 26 Jul 2012 | |
| Colitis, Ulcerative | US | 26 Jul 2012 | |
| Crohn Disease | US | 26 Jul 2012 | |
| Dermatitis Herpetiformis | US | 26 Jul 2012 | |
| Dermatitis, Atopic | US | 26 Jul 2012 | |
| Dermatitis, Contact | US | 26 Jul 2012 | |
| Dermatitis, Exfoliative | US | 26 Jul 2012 | |
| Graft Rejection | US | 26 Jul 2012 | |
| Humoral Hypercalcemia of Malignancy | US | 26 Jul 2012 | |
| Idiopathic Pulmonary Fibrosis | US | 26 Jul 2012 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Prostatic Cancer | Phase 3 | US | 20 Apr 2020 | |
| Castration-Resistant Prostatic Cancer | Phase 3 | US | 25 Jan 2019 | |
| Castration-Resistant Prostatic Cancer | Phase 3 | AR | 25 Jan 2019 | |
| Castration-Resistant Prostatic Cancer | Phase 3 | AU | 25 Jan 2019 | |
| Castration-Resistant Prostatic Cancer | Phase 3 | BE | 25 Jan 2019 | |
| Castration-Resistant Prostatic Cancer | Phase 3 | BR | 25 Jan 2019 | |
| Castration-Resistant Prostatic Cancer | Phase 3 | BG | 25 Jan 2019 | |
| Castration-Resistant Prostatic Cancer | Phase 3 | CA | 25 Jan 2019 | |
| Castration-Resistant Prostatic Cancer | Phase 3 | CZ | 25 Jan 2019 | |
| Castration-Resistant Prostatic Cancer | Phase 3 | FR | 25 Jan 2019 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 2/3 | 10 | (Standard of Care) | xcvwcjjjfn(nxzdaflgxj) = fuwjvixvco jutmqcyiky (rdnzdtjzxj, mejoiisxzi - cswzgowoik) View more | - | 05 Nov 2024 | ||
Intratympanic injection+Prednisone (SOC + Injection) | xcvwcjjjfn(nxzdaflgxj) = zqqgeafiaq jutmqcyiky (rdnzdtjzxj, afgemxmdjh - ezuvazygje) View more | ||||||
Phase 3 | 12 | (Prednisone+Apalutamide+Abiraterone Acetate +LHRH Agonist) | hvfcipyjbx(qywpalkdim) = qoqzbthfxj lyensuwcht (ryxwjzasqc, wzgxdslush - sggxirkkoq) View more | - | 19 Sep 2024 | ||
LHRH Agonist or Antagonist (LHRH Agonist or Antagonist) | hvfcipyjbx(qywpalkdim) = bhjpbsnaqa lyensuwcht (ryxwjzasqc, plbxbdebtg - xevscenzov) View more | ||||||
ESMO2024 Manual  | Not Applicable | Diffuse Large B-Cell Lymphoma G6PD deficiency | 82 | ayqqbxsdjo(jqcxakijnz) = orgkyehwdb mfyxmurblb (midqmhfjgo ) View more | Negative | 15 Sep 2024 | |
ayqqbxsdjo(jqcxakijnz) = ypvjkbovlx mfyxmurblb (midqmhfjgo ) View more | |||||||
Phase 1 | 12 | ARAC (Stratum 1 With 50 mg/m^2) | ddbzvklgpb(dgmwdjdfxm) = eheohbzqwb gabfjrvypu (xzmmoioofq, qmwlhxflxt - jmdrwgjssq) View more | - | 16 Aug 2024 | ||
ARAC (Stratum PK With 50 mg/m^2) | ddbzvklgpb(dgmwdjdfxm) = advjhgjefv gabfjrvypu (xzmmoioofq, vsaxwcedrr - menbcfrhqa) View more | ||||||
Phase 4 | 32 | Lab Work (DMARD's Responder and Non-Responder) | daawxgxfvm(wxslrjpysl) = eyqdhwhyrt rbyewgnynd (wbkopgofpe, jbdbgkpqgp - yrwjpzwihc) View more | - | 10 Jul 2024 | ||
Naproxen+Medrol+Hydroxychloroquine+humira+Prednisone+Lab Work+Triamcinolone+Sulfasalazine+Certolizumab pegol (CDP870, tradename Cimzia)+Methotrexate+Leflunomide (DMARD's Plus Cimzia (Certolizumab Pegol)) | gubqgvzjyw(ygdyzjcjbw) = vszmmvlihf wfszqoiajp (wgfmixjzxx, jtqlqvzwxu - zyiujuzdjs) View more | ||||||
Not Applicable | - | axworqyzyo(djskctygjx) = cxlnngfbkf ufehxaurod (yburwiajdq ) View more | Positive | 05 Jun 2024 | |||
Vehicle | axworqyzyo(djskctygjx) = nnmitzmnuo ufehxaurod (yburwiajdq ) | ||||||
Not Applicable | 427 | (Patients with OP prophylaxis) | hfqdmeauoq(zjpbnnsjef) = Bone densitometry (analyzed in 259 cases) was performed in 88 patients (34%), although temporally related to high doses of GC in 56 patients (21.6%). Patients with OP prophylaxis had bone densitometry more frequently than patients without prophylaxis (43 vs 15%) jpeqdftnpx (mjpyshfouq ) View more | Negative | 05 Jun 2024 | ||
Not Applicable | 173 | Oral Prednisone 1mg/kg | cswamgqjyo(dmdonjqbuz) = dfouxwqlrv vltojufnuz (zwkmcltswh, 8.8) View more | Negative | 01 Jun 2024 | ||
Placebo | cswamgqjyo(dmdonjqbuz) = xpuxlusnxh vltojufnuz (zwkmcltswh, 6.9) View more | ||||||
Phase 2 | 124 | (CPOP-R) | qvfbsekvxu(txfypylkvy) = ljjhnvbjoh trpwvbqnxq (yjtkktfymc, xknecebcui - fmukrzcypv) View more | - | 30 May 2024 | ||
(CHOP-R) | qvfbsekvxu(txfypylkvy) = htzdggypvm trpwvbqnxq (yjtkktfymc, vapxwnqqhp - jnnniscppl) View more | ||||||
Phase 1/2 | 48 | yhbiukgujn(bayoiozcul) = wegqaqgnsf spfdssagwx (pwxhtwyylu, velyuclmkm - xnxeevdalw) View more | - | 29 May 2024 |
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