Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.

Start Date09 Mar 2027

Sponsor / Collaborator

SWOG

[+1]

NCT07772245

/ Not yet recruitingPhase 2IIT

Phase II Trial of Retifanlimab With Trastuzumab and Pertuzumab Combination in HER2-Addicted Breast Cancer

The goal of this Clinical Trial is to find out how well 3 medicines (retifanlimab, trastuzumab and pertuzumab) work at treating HER2-positive breast cancer in Male and female patients, 18 or older. The main question aims to determine the pathologic response rate [residual cancer burden (RCB)- 0] in the breast and lymph nodes after 6 cycles of retifanlimab, trastuzumab and pertuzumab in patients with HER2-addicted breast cancer. Participants will will have at least 6 cycles of the study drug, assuming the participant is responding to and tolerating the treatment well. Every cycle will last about 21 days.

Start Date31 Dec 2026

Sponsor / Collaborator

The Methodist Hospital Research Institute

NCT07679269

/ Not yet recruitingPhase 2

An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.

The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.

Start Date15 Dec 2026

Sponsor / Collaborator

Novartis Pharmaceuticals Australia Pty Ltd.

100 Clinical Results associated with Trastuzumab

100 Translational Medicine associated with Trastuzumab

100 Patents (Medical) associated with Trastuzumab

11,877

Literatures (Medical) associated with Trastuzumab

01 Feb 2027·BIOELECTROCHEMISTRY

Super-antifouling electrochemical biosensor based on a biomimetic gemini zwitterionic interface for sensitive detection of therapeutic antibodies

Article

Author: Qu, Jia-Huan ; Zhao, Zheng ; Han, Hai ; Li, Haidong ; Yu, Wanqing ; Chen, Zhiwei ; Jiang, Zhengjin ; Hai, MingFang ; Wang, Qiqin

Biofouling, arising from the nonspecific adsorption of proteins, cells, and other biomolecules, remains a major challenge that compromises the stability and reliability of diagnostic and therapeutic platforms. To address this issue, a super-antifouling electrochemical aptasensor was developed by integrating a biomimetic "gemini" zwitterionic monomer (BSMMP) with polydopamine (PDA). The covalent assembly of BSMMP and PDA forms a multi-site anchoring layer that enables the stable functionalization of the affinity aptamer GC20. Owing to its dense hydration shell, the PDA-BSMMP hybrid interface acts as a physical barrier against nonspecific adsorption, maintaining electron-transfer stability in undiluted human serum. Differential pulse voltammetry confirmed that this interface markedly reduced biofouling-induced signal loss, limiting attenuation to less than 15%, nearly fourfold lower than that of the unmodified surface. The platform achieved a low limit of detection of 0.97 ng/mL, a broad linear range from 1 ng/mL to 100 μg/mL, and high selectivity for trastuzumab in a label-free format without secondary antibodies or additional signal amplification. Finally, this platform successfully quantified trastuzumab in serum from breast cancer patients, with results consistent with commercial ELISA kits. Overall, this super-antifouling aptasensor offers great potential for therapeutic drug monitoring, advancing zwitterionic interface-based biosensing strategies for point-of-care diagnostics.

01 Jan 2027·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development and application of antibody framework region-targeted cross-linking mass spectrometry for epitope screening within patient-derived immune complexes

Article

Author: Aibara, Nozomi ; Ohyama, Kaname ; Nakamura, Minoru ; Matsugi, Yuya ; Kutsuna, Yuki Jimbayashi ; Hamasaki, Maya ; Kawakami, Atsushi ; Yamazawa, Ryuji ; Nakashima, Mikiro

Identification of antibody-binding epitopes on antigens is essential for understanding the pathogenic roles of immune complexes (ICs) in autoimmune diseases and for the development of diagnostics and therapeutics. However, methods for direct epitope characterization of IC-antigens formed in vivo remain limited. Here, we investigated antibody framework region (FR)-targeted cross-linking mass spectrometry (XL-MS) as an approach to identify epitopes in patient-derived ICs. Four IC models with known epitopes (tumor necrosis factor alpha-adalimumab, tumor necrosis factor alpha-infliximab, human epidermal growth factor receptor 2-pertuzumab, and human epidermal growth factor receptor 2-trastuzumab) were analyzed using three cross-linkers of different lengths: bis(sulfosuccinimidyl) suberate (BS3), bis(sulfosuccinimidyl) glutarate (BS2G), and 1,1'-carbonyldiimidazole (CDI). BS3 preferentially generated antigen-FR cross-links, whereas CDI predominantly produced antigen-complementarity-determining region cross-links. Several cross-linked peptides contained antigen sequences overlapping previously reported epitopes, supporting the validity of this approach for epitope mapping. As a proof-of-concept clinical application, serum samples from patients with primary biliary cholangitis were analyzed using a targeted database containing four disease-associated autoantigens (PDC-E2, BCOADC-E2, OGDC-E2, and E3BP). Two candidate epitope peptides were identified. One corresponded to a known immunodominant epitope, whereas the other represented a novel candidate site supported by computational epitope prediction analysis. These findings demonstrate that FR-targeted XL-MS provides a strategy for identifying epitopes within patient-derived IC-antigens through the use of conserved antibody FRs. This approach may contribute to understanding antigen recognition mechanisms in autoimmune diseases and support the discovery of disease-relevant therapeutic targets.

31 Dec 2026·mAbs

Self-interaction nanoparticle spectroscopy predicts high-concentration viscosity of therapeutic IgG1 antibodies

Article

Author: Andersen, Nisana ; Luu, Steven ; Stephens, Nicole ; Bol, Karenna ; Mehta, Shrenik ; Heisler, Joel ; Swartz, Trevor ; Kovner, Daniel ; Rude, Erina ; Makowski, Emily ; Ibrahim, Julissa ; Zarzar, Jonathan ; Carter, Paul J. ; Stepurska, Kateryna ; Baginski, Tomasz ; Izadi, Saeed ; Paidi, Santosh Kumar ; O’Connor, Kelly

Predicting high-concentration viscosity of monoclonal antibodies is crucial for their development as therapeutics for subcutaneous delivery, but traditional experimental rheometry methods for assessing viscosity are low-throughput, which limits their utility. This study evaluates self-interaction nanoparticle spectroscopy (SINS) assays - specifically charge-stabilized SINS (CS-SINS) and PEG-stabilized SINS (PS-SINS) - for high-throughput viscosity prediction. We characterized 96 IgG₁ antibodies, assessing SINS against in silico descriptors and dynamic light scattering (DLS) data. CS-SINS showed strong correlation with charge, offering limited additional utility. In contrast, PS-SINS provided orthogonal information; integrating it with in silico data and DLS significantly improved random forest model accuracy for binary viscosity classification. PS-SINS measurements in multiple buffers captured complementary information, achieving comparable accuracy without DLS. Importantly, PS-SINS scores exhibited a strong logarithmic relationship with high-concentration viscosity in Fc variants of clinical antibodies (r = 0.72 and r = 0.85 for trastuzumab and omalizumab variants, respectively), suggesting a direct mechanistic link. Furthermore, PS-SINS performed reliably with one column-purified (protein A) samples, supporting its early-stage application. These findings establish PS-SINS as a high-throughput tool to accelerate the developability assessment of antibody candidates.

1,132

News (Medical) associated with Trastuzumab

12 Oct 2026

·www.biospace.com

Accord BioPharma Launches FILKRI™ (filgrastim-laha); Now Offers Both Long- and Short-Acting G-CSF Options

FILKRI is available with a permanent Q-code, standardizing the billing and reimbursement process across all sites of care. RALEIGH, N.C. , Oct. 12, 2026 /PRNewswire/ -- Accord BioPharma , Inc., the specialty division of Intas Pharmaceuticals, Ltd. , focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today the U.S. commercial launch of FILKRI™(filgrastim-laha), a biosimilar to Neupogen® (filgrastim). FDA-approved in January 2026, FILKRI represents Accord BioPharma's continued expansion into oncology supportive care and furthers the company's goal to bring 20 biosimilars to the U.S. market by 2030. 1 FILKRI is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML); to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; to reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). FILKRI is available in 300 mcg/0.5 mL and 480 mcg/0.8 mL prefilled syringe presentations, with pack sizes of one or 10 prefilled syringes per carton. 1 The addition of FILKRI expands Accord BioPharma's granulocyte colony-stimulating factor (G-CSF) portfolio, giving U.S. physicians access to both short- and long-acting treatment options through FILKRI and UDENYCA ® (pegfilgrastim-cbqv). These options help meet the individual needs of patients undergoing chemotherapy and their healthcare providers. 2 FILKRI will be manufactured end to end by Accord BioPharma's parent entity, Intas, and has been assigned a permanent Q-code (Q5172) by the U.S. Centers for Medicare & Medicaid Services (CMS), effective October 1, which will standardize the billing and reimbursement process across all sites of care. "The commercial launch of FILKRI with a permanent Q-code from day one is a significant milestone for Accord BioPharma and for cancer patients across the United States," said Chrys Kokino, President of Accord North America. "Having a permanent Q-code will simplify billing and streamline reimbursement, making it more timely and reliable for physicians treating patients." Addressing Critical Patient Needs in Neutropenia Management As a G-CSF, FILKRI is indicated for use across several clinical settings in which neutropenia or its complications may occur, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. Neutropenia is a condition characterized by lower-than-normal levels of neutrophils, a type of white blood cell that helps the body fight infections. Cancer treatments, including chemotherapy, can damage neutrophils or the bone marrow that produces them. 3 "With FILKRI, alongside our established UDENYCA pegfilgrastim franchise, Accord now offers physicians the choice between long-acting and short-acting biosimilar G-CSF treatments to suit their clinical needs and preferences," Kokino added. "This demonstrates our deep commitment to oncology supportive care and positions us as a comprehensive partner for the oncology community." Filgrastim biosimilars have become well established in the U.S. market, accounting for approximately 77% of filgrastim market share as of the fourth quarter of 2025. 4 Expanding Access Through Competitive Pricing and Patient Support Through AccordCares®, a dedicated patient support program, the company is launching FILKRI with comprehensive patient resources, including benefits investigation and co-pay assistance, designed to connect patients to the information and resources they need, building on the proven foundation established with UDENYCA. "At Accord, we believe that cost shouldn't prevent patients from receiving the cancer care they need," said Nuvan Dassanaike, Senior Vice President, Digital and Marketing Strategy & Operations, Accord BioPharma. "With FILKRI, we're continuing to build on our track record of bringing high-quality biosimilars to market that provide physicians more choice and can make a real difference in patient care and patient affordability. The permanent Q-code further enhances our ability to expand patient access from launch." Building on Proven Leadership in Oncology Supportive Care "The launch of FILKRI in the United States demonstrates our unwavering commitment to building a comprehensive oncology supportive care portfolio that addresses urgent medical needs," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape by introducing biosimilars to the U.S. market. As our presence in the biosimilar market continues to grow, so does our commitment to offering high-quality, affordable alternatives to reference drugs, so that more patients can access the treatments they need." FDA approval of FILKRI was based on data demonstrating that FILKRI is highly similar to Neupogen, with no clinically meaningful differences. 1 IMPORTANT SAFETY INFORMATION FILKRI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSFs) such as filgrastim or pegfilgrastim products. Splenic Rupture: Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Acute Respiratory Distress Syndrome (ARDS): ARDS has been reported in patients receiving filgrastim products . Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS . Discontinue FILKRI in patients with ARDS. Serious Allergic Reactions: Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products . The majority of reported events occurred upon initial exposure . Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment . Permanently discontinue FILKRI in patients with serious allergic reactions. Sickle Cell Disorders: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products . Discontinue FILKRI if sickle cell crisis occurs. Glomerulonephritis: Has occurred in patients receiving filgrastim products . Diagnoses were based on azotemia, hematuria, proteinuria, and renal biopsy . Generally, events resolved after dose reduction or discontinuation of filgrastim products . If causality is likely, consider dose-reduction or interruption of FILKRI. Alveolar Hemorrhage and Hemoptysis: Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, have been reported in FILKRI-treated healthy donors undergoing peripheral blood progenitor cell (PBPC) collection mobilization . Hemoptysis resolved with discontinuation of filgrastim products. The use of FILKRI for PBPC mobilization in healthy donors is not an approved indication. Capillary Leak Syndrome (CLS): CLS has been reported after G-CSF administration, including filgrastim products and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity, and may be life-threatening if treatment is delayed . Patients with symptoms should be closely monitored and receive appropriate treatment. Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Patients with Severe Chronic Neutropenia (SCN ): Confirm the diagnosis of SCN before initiating FILKRI therapy. MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim administration in patients with abnormal cytogenetics or MDS are unknown. Monitor patients for signs and symptoms of MDS/AML in these settings. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing FILKRI should be carefully considered. Patients with Breast and Lung Cancer : MDS and AML have been associated with the use of filgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings. Thrombocytopenia: Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts. Leukocytosis: Patients with Cancer Receiving Myelosuppressive Chemotherapy : White blood cell counts ≥ 100,000/mm 3 were observed in about 2% of patients who received filgrastim products at dosages above 5 mcg/kg/day. Discontinue FILKRI if the absolute neutrophil count (ANC) surpasses 10,000/mm 3 after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy with FILKRI. Discontinuation of filgrastim therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days. Cutaneous Vasculitis: Moderate or severe cases of cutaneous vasculitis has been reported in patients treated with filgrastim products . Most reports involved patients with SCN receiving long-term filgrastim therapy . Hold FILKRI therapy in patients with cutaneous vasculitis . FILKRI dose may be reduced when the symptoms resolve and the ANC has decreased. Potential Effect on Malignant Cells: FILKRI is a growth factor that primarily stimulates neutrophils. The granulocyte colony-stimulating factor (G-CSF) receptor through which FILKRI acts has also been found on tumor cell lines. The possibility that FILKRI acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established. Simultaneous Use with Chemotherapy and Radiation Not Recommended: The safety and efficacy of FILKRI given simultaneously with cytotoxic chemotherapy and radiation have not been established . Do not use FILKRI 24 hours before or after administration of cytotoxic chemotherapy . The safety and efficacy of FILKRI have not been evaluated in patients receiving concurrent radiation therapy . Avoid the simultaneous use of FILKRI with chemotherapy and radiation therapy. Nuclear Imaging: Increased hematopoietic activity of the bone marrow has been associated with transient positive bone-imaging changes on nuclear imaging. Aortitis: Aortitis has been reported in patients receiving filgrastim products . It may occur as early as the first week after start of therapy . Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) . Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue FILKRI if aortitis is suspected. The most common adverse reactions in patients: with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea with AML (≥ 2% difference in incidence) are pain, epistaxis and rash with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) is rash with severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia INDICATIONS FILKRI is a leukocyte growth factor indicated to: Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) For more information, please see the full Prescribing Information . About Accord BioPharma Accord BioPharma, Inc. is the U.S. specialty division of Intas Pharmaceuticals, Ltd., one of the world's most experienced biosimilar developers. Focused on the therapeutic areas of oncology, immunology, and CNS, Accord BioPharma is committed to expanding patient access to high-quality, affordable biologic therapies. The company's FDA-approved commercial portfolio includes UDENYCA® (pegfilgrastim-cbqv) – a biosimilar to NEULASTA® (pegfilgrastim); FILKRI™ (filgrastim-laha) – a biosimilar to NEUPOGEN® (filgrastim); IMULDOSA® (ustekinumab-srlf) – a biosimilar to STELARA® (ustekinumab); HERCESSI™ (trastuzumab-strf) – a biosimilar to HERCEPTIN® (trastuzumab); OSVYRTI® (denosumab-desu) – a biosimilar to Prolia® (denosumab); JUBEREQ® (denosumab-desu) – a biosimilar to Xgeva® (denosumab); ENNUMO™ (pegfilgrastim-pccg) – a biosimilar to NEULASTA® (pegfilgrastim); and CAMCEVI® (leuprolide mesylate) injectable emulsion. Accord BioPharma has received FDA approval on additional products including IMMGOLIS™ (golimumab-sldi) – a biosimilar to Simponi® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) – a biosimilar to Simponi Aria® (golimumab). The company's strategic goal is to launch 20 biosimilar products in the U.S. by 2030. For more information, visit . References: FILKRI (filgrastim-laha) injection. Prescribing Information. Accord BioPharma. UDENYCA Prescribing Information. Coherus BioSciences. Cleveland Clinic. Neutropenia. Updated June 9, 2022. Accessed October 2, 2026. . Samsung Bioepis. Biosimilar Market Report . 13th ed., Q2 2026. All trademarks, logos and brand names are the property of their respective owners. Contact: abipr@accordhealthcare.com View original content to download multimedia: SOURCE Accord BioPharma

Drug ApprovalRadiation Therapy

09 Oct 2026

·www.biopharmadive.com

FDA review docs spark Revolution sell-off; Zealand diabetes data underwhelm analysts

Today, a brief rundown of news involving Revolution Medicines and Zealand Pharma, as well as updates from Pfizer, Ultragenyx and TCGX that you may have missed.Shares of Revolution Medicine fell 6% Thursday following release of Food and Drug Administration review documents suggesting the companys closely watched pancreatic cancer drug Rasonque might be less effective in certain patients for which its approved. Rasonque gained FDA approval in August based on data showing it nearly doubled survival compared to chemotherapy in patients whod already progressed on chemo. However, the FDA documents showed that tumor responses were markedly better than chemo in trial enrollees with a specific KRAS mutation called G12V. The difference was more modest among those with a G12D mutation who represent the largest share of pancreatic cancer patients and worse in people with a G12R mutation. Many Wall Street analysts rushed to Revolutions defense, arguing in client notes that the sell-off was overdone, misguided or an investor overreaction. Still, Leerink Partners analyst Andrew Berens referred to the disclosure as a crack in the armor for Rasonque and viewed it as an opportunity for competitors with G12D-specific inhibitors or next-generation medicines. Jonathan GardnerZealand Pharma said Wednesday its experimental, Roche-partnered drug petrelintide helped people with obesity and diabetes in a Phase 2 trial lose up to 9% of their body weight over 28 weeks, equating to 7 percentage points more than those who got a placebo. Petrelintide was also associated with clinically relevant blood sugar reductions that were anywhere from about 0.6 to 0.9 percentage points better than a placebo. Multiple Wall Street analysts noted that weight loss numbers were comparable to an Eli Lilly drug that, like petrelintide, is an amylin analog and a potential alternative to GLP-1 medicines. They also applauded the therapys seemingly benign safety profile. Petrelintides effects on blood sugar, though, were viewed as less impressive. The drug will likely be used primarily in the maintenance setting, William Blair analyst Andy Hsieh predicted in a client note. Jonathan GardnerThe FDA has expanded use of Pfizers HER2-targeting breast cancer drug Tukysa. Previously developed by Seagen, Tukysa first came to market in 2020 as a second-line treatment for HER2-positive breast tumors. The new clearance makes Tukysa available in the frontline setting, where itll be prescribed as part of a chemotherapy-free maintenance regimen also involving the targeted medications Herceptin and Perjeta. That regimen was associated with a 36% reduction in the risk of disease progression or death when compared to Herceptin and Perjeta alone in a Phase 3 trial. Delilah AlvaradoUltragenyx has gained $210 million by selling one of two regulatory fast passes it was recently awarded by the FDA. The priority voucher Ultragenyx sold on Wednesday was related to the clearance of Glenglycos, a gene therapy for a rare glycogen storage disease. It received another upon the approval of the Sanfilippo gene therapy Fayuvi. The sale is an incrementally positive development for Ultragenyx, as itll significantly strengthen the companys balance sheet, wrote William Blair analyst Lachlan Hanbury-Brown. The company said it would consider cost cuts last month following the failure of a key experimental treatment for Angelman syndrome. Delilah AlvaradoBiotech investment firm TCGX said Wednesday it closed a $600 million fund that will support biotechnology companies in Asia. Known as TCGX Asia Life Sciences Fund I, the investment vehicle will operate separately from, but in close synergy with, two other TCGX funds that back biotechs in the U.S. and Europe. It is backed by a diverse group of international institutional investors, said TCGX, without providing specifics. The firm is opening new offices in Shanghai and Hong Kong alongside the funds launch. Delilah Alvarado '

Phase 3Drug ApprovalPhase 2Clinical ResultGene Therapy

08 Oct 2026

·www.businesswire.com

Pfizer’s TUKYSA Regimen Receives FDA Approval as Front-Line Maintenance Treatment for HER2+ Metastatic Breast Cancer

Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved TUKYSA® (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive (HER2+) breast cancer following induction treatment. The approval expands the use of TUKYSA to frontline, an earlier stage of metastatic disease, offering a new chemotherapy-free maintenance treatment option that may help further delay disease progression. “Since its first approval in 2020, TUKYSA has become an important treatment for patients with second-line HER2+ metastatic breast cancer. Today's FDA approval marks the next chapter for TUKYSA, bringing it into the front-line maintenance setting and offering patients a chemotherapy-free option that can help delay disease progression after initial treatment. This approval reflects Pfizer’s commitment to advancing therapies across the breast cancer treatment journey and delivering meaningful new options for people living with metastatic breast cancer.” - Aamir Malik, Executive Vice President, Chief U.S. Commercial Officer, Pfizer “The treatment landscape for HER2+ metastatic breast cancer has evolved dramatically over the past decade, but many patients still experience disease progression despite initial benefit from therapy. The HER2CLIMB-05 findings support TUKYSA plus trastuzumab and pertuzumab as a chemotherapy-free maintenance strategy that allows us to target HER2-positive tumors from multiple angles and can help prolong disease control.” - Erika Hamilton, M.D., principal investigator of HER2CLIMB-05 and Chief Development Officer, Late Phase & Director, Breast Cancer Research for Sarah Cannon Research Institute (SCRI) Prolonged Median Progression-Free Survival (PFS) : The primary endpoint analysis showed a 35.9% reduction in the risk of disease progression or death among patients treated with TUKYSA, trastuzumab, and pertuzumab compared to those treated with placebo, trastuzumab, and pertuzumab, following induction treatment, as assessed by the investigator (hazard ratio of 0.64, 95% confidence interval (CI): 0.51-0.80; 2-sided p<0.0001). Median investigator-assessed PFS for patients in the TUKYSA arm was 24.9 months (95% CI, 21.3-not reached) compared to 16.3 months (95% CI, 12.6-18.7) in the placebo arm, representing a difference of 8.6 more months that patients lived without their cancer worsening. Safety Profile: The safety and tolerability of TUKYSA was generally consistent with its known safety profile, with the exception of increased severity of hepatotoxicity. The majority of hepatotoxicity events were generally asymptomatic and reversible with dose modification and/or discontinuation. The most commonly reported adverse events (≥20%) were diarrhea, musculoskeletal pain, hepatotoxicity, nausea, fatigue, rash, and vomiting. Serious adverse reactions in ≥1% of patients included hepatotoxicity (3.9%), including one patient who experienced a fatal adverse reaction of drug-induced liver injury. Published Previously: Results from HER2CLIMB-05 were published in the Journal of Clinical Oncology and presented at the 2025 San Antonio Breast Cancer Symposium (SABCS). The HER2CLIMB-05 trial is a randomized, double blind, placebo-controlled, pivotal Phase 3 study evaluating the efficacy and safety of TUKYSA compared to placebo, both in combination with trastuzumab and pertuzumab, as maintenance therapy for patients with HER2+ metastatic breast cancer (MBC) following induction therapy in the front-line setting. HER2 is overexpressed in up to 15-20% of breast cancers and is associated with poor prognosis, with an estimated five-year survival rate of 41% to 47%, depending on hormone receptor status. 1-3 Trial participants who completed induction therapy of trastuzumab, pertuzumab, and a taxane, with no evidence of progression, were randomized to receive TUKYSA in combination with trastuzumab plus pertuzumab (n=326) or placebo in combination with trastuzumab plus pertuzumab (n=328). The primary endpoint is PFS as assessed by the investigator. Overall survival is a key secondary endpoint. Continuing Pfizer’s Legacy of Leadership in Breast Cancer Pfizer has been a leader in breast cancer for over 25 years, and today we have five medicines and one biosimilar approved to treat different subtypes of the disease, reaching over 4.9 million patients worldwide. In the U.S., TUKYSA is already a National Comprehensive Cancer Network® (NCCN®) Category 1 second-line plus treatment for HER2+ MBC patients. This approval extends the reach of TUKYSA as part of a front-line maintenance regimen, bringing patients a new option to delay disease progression without the need for continued chemotherapy and helping physicians further individualize treatment plans to best meet the needs of each unique patient. TUKYSA (tucatinib) is an orally administered tyrosine kinase inhibitor of HER2. TUKYSA is approved in combination with trastuzumab and pertuzumab for the maintenance treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment. TUKYSA has also been approved in combination with trastuzumab and capecitabine to treat adults with HER2-positive advanced unresectable or MBC, including patients with brain metastases who have received one or more prior anti-HER2 breast cancer treatments in the metastatic setting. The full U.S. Prescribing Information for TUKYSA can be found here. There may be a delay as the document is updated with the latest information. It will be available as soon as possible. Please check back for the updated full information shortly. At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancers, genitourinary cancers, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. References Tarantino P, et al. ESMO expert consensus statements (ECS) on the definition, diagnosis, and management of HER2-low breast cancer. J An Onc . 2023;34(8):645-659. Wolff AC, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline focused update. J Clin Oncol . 2018;36(20):2105-2122. National Cancer Institute. The Surveillance, Epidemiology, and End Results (SEER) Program: Cancer stat facts: Female breast cancer subtypes. https://seer.cancer.gov/statfacts/html/breast-subtypes.html The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug ApprovalAccelerated Approval

100 Deals associated with Trastuzumab

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KEGG	Wiki	ATC	Drug Bank
D03257	Trastuzumab	L01XC03	DB00072

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
HER2 positive salivary gland cancer	Japan	Chugai Pharmaceutical Co., Ltd.	25 Nov 2021
HER2-positive gastric cancer	Japan	Chugai Pharmaceutical Co., Ltd.	10 Mar 2011
Stomach Cancer	United States	Genentech, Inc.	20 Oct 2010
Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	04 Apr 2001
Early Stage Breast Carcinoma	European Union	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Norway	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	European Union	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Norway	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	European Union	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Norway	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	European Union	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Iceland	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Colorectal Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Gallbladder Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Hematologic Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Lung Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Ovarian Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Pancreatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Prostatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Salivary Gland Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Skin Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EMBRACE-MRI (ESC2026)	Not Applicable	HER2 Positive Breast Cancer HER2-positive	153	Anthracycline and Trastuzumab	oufvjjdwbt(dgqovhpqcc) = radwerewed kjesayegbo (xsbezmgdyr ) View more	Positive	30 Aug 2026
NCT04266249 (EA1181, Pubmed \| J Clin Oncol)	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2+/ER- \| HER2+/ER+	2,175	Neoadjuvant taxane, trastuzumab, and pertuzumab (THP)	ovucrsgmqt(ljzjmfcnsp) = xnoqbrwryz rkatzvfldl (upztozfphs )	Positive	20 Aug 2026
				Neoadjuvant taxane, trastuzumab, and pertuzumab (THP) (HER2+/ER-)	ovucrsgmqt(ljzjmfcnsp) = ctjxfsjqpi rkatzvfldl (upztozfphs )
NCT03716180 (DAPHNe, Pubmed \| JAMA Oncol)	Phase 2	Neoadjuvant ERBB2-positive	98	Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab (THP) (Stage II to III ERBB2-Positive Breast Cancer)	obgbjgoqsv(ywxgozjfdx) = qclcuipwkg zcesyswyni (huqbybkhim, 97 - 100) View more	Positive	01 Aug 2026
NCT02252887 (CTgov)	Phase 2	Advanced HER2-Positive Breast Carcinoma \| Metastatic human epidermal growth factor 2 positive carcinoma of breast	45	Trastuzumab+Gemcitabine+Pertuzumab	vonxjhrsrz = upzyvmysoz hpvibarvxc (auvocxotvr, pbdmmnyntp - gvcylmfvxe) View more	-	24 Jul 2026
NCT03272477 (WSG TP-II, Pubmed \| J Clin Oncol)	Phase 2	Hormone receptor positive HER2 positive breast cancer Neoadjuvant hormone receptor-positive \| human epidermal growth factor receptor 2 (HER2)-positive	207	Neoadjuvant paclitaxel + trastuzumab + pertuzumab	qrcalkffub(iegofllqat) = voplajvlbl fpvheyogfy (aveqsllwpx, 90.5 - 99.3) View more	Positive	20 Jul 2026
				Neoadjuvant endocrine therapy + trastuzumab + pertuzumab	qrcalkffub(iegofllqat) = vbcvhabodd fpvheyogfy (aveqsllwpx, 86.6 - 97.9) View more
ESMO_GI2026	Not Applicable	Metastatic HER2 positive gastroesophageal junction cancer First line HER2-positive	480	Trastuzumab +platinum-fluoropyrimidine chemotherapy	vclehwgzay(mgevoiovks) = vmbvklynca kqyjhafksp (sviwtjpwyp )	Negative	02 Jul 2026
				platinum-fluoropyrimidine chemotherapy without targeted therapy	vclehwgzay(mgevoiovks) = ewaawvoalj kqyjhafksp (sviwtjpwyp )
ESMO_GI2026	Not Applicable	HER2-positive gastric cancer First line HER2-positive	81	Trastuzumab with platinum-fluoropyrimidine chemotherapy	ivbnghrxuu(vdrilietau) = ekjfqcqtyi vyijsluzjd (rbedbokllh ) View more	Positive	02 Jul 2026
ESMO_GI2026 \| ESMO_GCC2026	Not Applicable	HER2 Positive Colorectal Cancer First line	26	chemotherapy with anti-EGFR	bhotwqsqfb(jhdmhvomcj) = vbecprvdlo uclozawxva (ttwnvoiksn )	Positive	02 Jul 2026
				chemotherapy with anti-VEGF	bhotwqsqfb(jhdmhvomcj) = rbduvpkdnk uclozawxva (ttwnvoiksn )
ESMO_GI2026	Not Applicable	HER2 Positive Stomach Adenocarcinoma Maintenance HER2-positive	240	Maintenance trastuzumab	jeeabnkywt(qmkbqjowig) = vnmfzebney iflushrrnw (xgpuhtmfdh ) View more	Positive	02 Jul 2026
				Maintenance trastuzumab + fluoropyrimidines	jeeabnkywt(qmkbqjowig) = xmmdxclobv iflushrrnw (xgpuhtmfdh ) View more
ESC2026	Not Applicable	Heart Diseases	16	HER2-targeted therapy (Trastuzumab and/or trastuzumab-based ADC, with or without Pertuzumab)	nhetauuugu(pvhqnivcpz) = jwuqoyeeqk ohamdmwour (irywykobrq ) View more	Positive	19 Jun 2026

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