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Trastuzumab News
FDA Approves Hercessi (trastuzumab-strf), a Biosimilar to Herceptin
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...
Enhertu Approved in the US as First Tumor-Agnostic HER2-Directed Therapy for Previously Treated Patients with Metastatic HER2-Positive Solid Tumors
April 6, 2024 – AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC...
Neratinib, Fulvestrant, Trastuzumab Combo Aids Metastatic Breast Cancer
TUESDAY, Nov. 28, 2023 – For patients with hormone receptor (HR)-positive HER2-mutant metastatic breast cancer (MBC) with progression on cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy,...
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
October 26, 2023 – Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and...
ESMO: Pembrolizumab + Chemo, Trastuzumab Beneficial in Gastroesophageal Cancer
WEDNESDAY, Oct. 25, 2023 – For patients with HER2-positive gastroesophageal junction (GEJ) adenocarcinoma, pembrolizumab improves progression-free survival when combined with chemotherapy and...
Seagen Announces FDA Accelerated Approval of Tukysa (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer
BOTHELL, Wash.--(BUSINESS WIRE) January 19, 2023 – Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tukysa (tucatinib)...
FDA Approves Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for HER2-Positive Breast Cancer
South San Francisco, CA – June 29, 2020 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Phesgo,...
FDA Approves Kanjinti (trastuzumab-anns), a Biosimilar to Herceptin
THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ – Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Kanjinti...
FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers
South San Francisco, CA – February 28, 2019 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin...
FDA Approves Trazimera (trastuzumab-qyyp), a Biosimilar to Herceptin
March 11, 2019 - Pfizer Inc. today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the ...
FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin
INCHEON, KOREA – January 21, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Her...
FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin
INCHEON, South Korea & JERUSALEM--(BUSINESS WIRE) December 14, 2018 --Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has...
FDA Approves Ogivri (trastuzumab-dkst), a Biosimilar to Herceptin
December 1, 2017 – The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic...
FDA Approves Herceptin For HER2-Positive Metastatic Stomach Cancer
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct 20, 2010 - Genentech, a member of the Roche Group, today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin (trastuzumab)...
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Breast Cancer, Metastatic, Breast Cancer - Adjuvant, Breast Cancer, Gastric Cancer