Filgrastim (Amgen)

- Presentation Today, Monday, May 6, 2024 in Atlanta, Georgia - TEL AVIV, Israel, May 6, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new economic model data will be presented on APHEXDA® (motixafortide) for CD34+ hematopoietic stem cell (HSC) mobilization in patients with multiple myeloma at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) – The Professional Society for Health Economics and Outcomes Research – 2024 conference, taking place May 5-8, 2024, in Atlanta, Georgia. Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and prolongs survival for patients with this cancer type.1 Historically, depending on induction regimens and mobilization strategies, approximately 50% to 75% of patients required more than one apheresis session to collect a target number of cells.2,3 Uncertainty in stem cell mobilization and the possible need for multiple apheresis sessions may result in psychological and logistical burden on patients, in addition to financial and operational inefficiencies for apheresis centers. The new economic model assessed the cost and healthcare resource utilization impacts of multiple apheresis attempts via a comparison between daily filgrastim (G-CSF) alone and in combination with APHEXDA, and an indirect comparison between daily filgrastim used with either plerixafor or APHEXDA, using drug costs from Micromedex, procedure costs from CMS.gov and data for apheresis days obtained from clinical trials and product labels. The data are expected to be published in Value in Health, Volume 27, Issue 6, S1 (June 2024.) Poster Presentation at ISPOR 2024 Georgia World Congress Center, Atlanta, Georgia Poster Session Details Poster: Number EE148 Title: The Institutional Level Impact of Additional Apheresis Days for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation on Costs and Healthcare Resource Utilization Presenter: Jeffrey R Skaar, PhD, Trinity Life Sciences, New York, NY and Jennifer L Lessor, MPH, BioLineRx USA, Inc., Waltham, MA Poster Session: Economic Evaluation Date: Monday, May 6, 2024 Time: 3:30 PM - 6:30 PM The new economic model data to be presented at ISPOR 2024 builds on the evaluation of APHEXDA for CD34+ HSC mobilization in patients with multiple myeloma in apheresis center operations. About the GENESIS Trial GENESIS (NCT 03246529) is a 2-part, Phase-3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim (G-CSF), compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study. The primary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in one apheresis session. About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow. According to the American Cancer Society, in 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and nearly 13,000 people will die from the disease in the U.S.4 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. About APHEXDA® APHEXDA (motixafortide) is a CXCR4 antagonist with long receptor occupancy (greater than 72 hours) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma.5 INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide. WARNINGS AND PRECAUTIONS Anaphylactic Shock and Hypersensitivity Reactions: Anaphylactic shock and hypersensitivity reactions have occurred. Premedicate all patients with a triple drug premedication regimen that includes an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor approximately 30-60 minutes prior to each dose of APHEXDA. Administer APHEXDA in a setting where personnel and therapies are immediately available for treatment of anaphylaxis and other systemic reactions. Monitor patients for 1 hour following APHEXDA administration and manage reactions promptly. Patients receiving negative chronotropic drugs (e.g., beta-blockers) may be more at risk for hypotension in the event of a hypersensitivity reaction and these drugs, when appropriate, should be replaced with non-chronotropic drugs. Injection Site Reactions: Injection site reactions (73%) including pain (53%), erythema (27%), and pruritus (24%) have occurred. Severe reactions occurred in 9% of patients. Premedicate with an analgesic premedication (e.g., acetaminophen) prior to each APHEXDA dose. Use analgesic medication and local treatments post-dose, as needed. Tumor Cell Mobilization in Patients with Leukemia: For the purpose of hematopoietic stem cell (HSC) mobilization, APHEXDA may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, APHEXDA is not intended for HSC mobilization and harvest in patients with leukemia. Leukocytosis: Administering APHEXDA in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during APHEXDA use. Potential for Tumor Cell Mobilization: When APHEXDA is used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied. Embryo-fetal Toxicity: Based on its mechanism of action, APHEXDA can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment with APHEXDA and advise use of effective contraception during treatment and for 8 days after the final dose. ADVERSE REACTIONS The most common adverse reactions (incidence >20%) in patients treated with APHEXDA were injection site reactions [73%, including pain (53%), erythema (27%), pruritus (24%)]; pruritus (38%); flushing (33%); back pain (21%). USE IN SPECIFIC POPULATIONS Pregnancy: Please see the important information in Warnings and Precautions under Embryo-fetal Toxicity. Lactation: There are no data on the presence of motixafortide in human milk, the effects on the breastfed child, or the effects on milk production. Advise females that breastfeeding is not recommended during treatment with APHEXDA and for 8 days after the final dose. Pediatric Use: The safety and effectiveness of APHEXDA have not been established in pediatric patients. Please see the accompanying full Prescribing Information. About BioLineRx BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA® (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside. Learn more about who we are, what we do, and how we do it at , or on Twitter and LinkedIn.  Forward Looking Statement Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the execution of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether BioLineRx's collaboration partners will be able to execute on collaboration goals in a timely manner; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, operationalize and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; the impact of any resurgence of the COVID-19 pandemic, the Russian invasion of Ukraine, the declared war by Israel against Hamas and the military campaigns against Hamas and other terrorist organizations, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 26, 2024. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law. Kumar SK, et al. Blood. 2008;111(5):2516-2520. Dhakal B, Zhang M, Burns L, et al. Haematologica. 2023;106(8):2257-2260. Ahmed N, Li L, Rojas P, et al. Bone Marrow Transplant. 2021;56(6):1458-1461. American Cancer Society. Key Statistics About Multiple Myeloma. Atlanta, Ga: American Cancer Society; 2024. APHEXDA. Prescribing Information. BioLineRx Ltd; 2023. Contacts: United States John Lacey BioLineRx [email protected] Israel Moran Meir LifeSci Advisors, LLC [email protected] SOURCE BioLineRx

HERCESSI™, a biosimilar to Herceptin®, is the first FDA-approved biosimilar from Accord BioPharma, with several more in development DURHAM, N.C., April 29, 2024 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. "The approval of HERCESSI—our first biosimilar to be approved in the U.S.—marks an important milestone for Accord BioPharma in our efforts to improve access for patients," said Chrys Kokino, U.S. president of Accord. "Because breast and gastric cancers are among the most common types of cancer and cancer can have a high-cost burden for patients, there is a need to provide these patients with additional treatment options that may be more affordable, such as biosimilars." HERCESSI is indicated for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. HER2 cancers in general are particularly aggressive cancer types that respond well to targeted treatment. HERCESSI works by binding to and inactivating the HER2 receptor, slowing down cell replication. FDA approval was granted based on a comprehensive package of analytical, pre-clinical, and clinical data, which showed HERCESSI and its reference product, Herceptin (trastuzumab) are highly similar in terms of efficacy, safety, and quality. The clinical program for HERCESSI included three studies since 2015 to demonstrate pharmacokinetic (PK) comparability and clinical efficacy/safety similarity between HERCESSI and its reference product. The studies include two Phase 1 comparative single-dose PK equivalence studies conducted in healthy volunteers (HLX02-HV01 and HLX02-HV02), and a supportive Phase 3, double-blind, randomized clinical efficacy and safety comparability study in patients with HER2-overexpressing metastatic breast cancer in combination with docetaxel (HLX02-BC01). The PK comparability and clinical efficacy/safety similarity exercised in HLX02-HV02 and HLX02-BC01 adheres to current biosimilar guidance from the FDA. The safety pro HERCESSI has been shown to be consistent with the safety pro the reference product Herceptin. The data demonstrate that there are no clinically meaningful differences between HERCESSI and Herceptin in the populations studied and support biosimilarity between the two therapies. "Our first FDA-approved biosimilar is an important achievement for our U.S. specialty business, but we're just getting started. We aspire to deliver one of the deepest portfolios of biosimilars to patients and providers alike, and to help the U.S. health system achieve significant savings," said Binish Chudgar, vice chairman and managing director, Intas Pharmaceuticals. "Our vision to make affordable medicines available forms the bedrock of the company, and this work advances that vision to provide value and promote access for all the key stakeholders we engage along the treatment journey." HERCESSI was approved by the FDA at a dosage of 150mg. A 420mg-strength version of HERCESSI is also in development from Accord BioPharma, with an FDA decision anticipated in Q4 2024. HERCESSI was originally developed by Accord's business partner Shanghai Henlius Biotech, Inc. headquartered in Shanghai, China. In 2021, Henlius granted Accord BioPharma the exclusive rights to develop and commercialize HERCESSI in the U.S. and Canada. Mr. Jason Zhu, executive director, chief executive officer, and chief financial officer of Henlius remarked, "Henlius independently developed HLX02 (or HERCESSI in the U.S.) in accordance with the NMPA, the European Medicines Agency (EMA), the FDA, and other international biosimilar guidelines. It is Henlius' first FDA-approved product. Our patient-centered approach has led us to unwaveringly explore high-quality, effective, affordable, and accessible treatment options, and our determination to promote HLX02 in more than 40 markets around the world is Henlius' response to patients' concerns. We look forward to reaching more patients in North America and providing them with more cost-effective access to high-quality biologics." HERCESSI is the first U.S.-FDA-approved biosimilar from Accord BioPharma, which has also submitted a Biologics License Application to the FDA for biosimilar versions of pegfilgrastim, filgrastim and ustekinumab. Accord BioPharma is planning on introducing several additional biosimilars to the U.S. market during the next five years. Boxed Warning and Additional Important Safety Information HERCESSI™ (trastuzumab-strf) for injection, for intravenous use. HERCESSI (trastuzumab-strf) is biosimilar to HERCEPTIN (trastuzumab). WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greater risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue HERCESSI for cardiomyopathy. Infusion Reactions, Pulmonary Toxicity: Discontinue HERCESSI for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. Cardiomyopathy HERCESSI administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. HERCESSI can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. HERCESSI can also cause asymptomatic decline in LVEF by echocardiogram or MUGA scan. Evaluate left ventricular function in all patients prior to and during treatment with HERCESSI and every 6 months for at least 2 years following completion of HERCESSI as a component of adjuvant therapy. Discontinue HERCESSI treatment in patients receiving adjuvant therapy and withhold HERCESSI in patients with metastatic disease for clinically significant decrease in left ventricular function. The safety of continuation or resumption of HERCESSI in patients with trastuzumab product-induced left ventricular cardiac dysfunction has not been studied. Infusion Reactions With trastuzumab products, serious and fatal infusion reactions have been reported. Severe reactions, which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension were usually reported during or immediately following the initial infusion. Interrupt HERCESSI infusion for dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen). Monitor patients until symptoms completely resolve. Discontinue HERCESSI for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions. Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia. Embryo-Fetal Toxicity Exposure to HERCESSI during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception. Verify the pregnancy status of females of reproductive potential prior to the initiation of HERCESSI. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of HERCESSI. Advise female patients to contact their healthcare provider with a known or suspected pregnancy. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for HERCESSI treatment and any potential adverse effects on the breastfed child from HERCESSI or from the underlying maternal condition. This consideration should also take into account the trastuzumab product wash out period of 7 months. Pulmonary Toxicity HERCESSI administration can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity. Discontinue HERCESSI in patients experiencing pulmonary toxicity. Exacerbation of Chemotherapy-Induced Neutropenia In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not. Most Common Adverse Reactions The most common adverse reactions associated with trastuzumab products in the adjuvant and metastatic breast cancer (≥ 10%) are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. The most common adverse reactions associated with trastuzumab products in metastatic gastric cancer (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. Indications Adjuvant Breast Cancer HERCESSI (trastuzumab-strf) is indicated for adjuvant treatment of HER2-overexpressing nodepositive or nodenegative (ER/PR-negative or with one high-risk feature) breast cancer: as part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline-based therapy Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. Metastatic Breast Cancer HERCESSI is indicated: in combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. Metastatic Gastric Cancer HERCESSI is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. Click here for full Prescribing Information, including Boxed Warnings. About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access and options for patients and deliver savings to the U.S. healthcare system, and is striving to offer one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com. References: 1. HERCESSI (trastuzumab-strf). Prescribing Information. Accord BioPharma; April 2024. 2. Accord BioPharma. Data on file. Herceptin® is a registered trademark of Genentech, Inc. Contact: Nuvan Dassanaike Senior Vice President Digital and Marketing Strategy & Operations Nuvan_Dassanaike@Accord-Healthcare.com