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Herceptin 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...

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...

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)...

FDA Medwatch Alert: Herceptin 440 mg Vials and BWFI Diluent

[Posted 07/10/2008] Genentech informed healthcare professionals that an increased number of complaints were received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic...

FDA Medwatch Alert: Herceptin (trastuzumab)

[Posted 08/31/2005] Genentech and FDA notified healthcare professionals of updated cardiotoxicity information related to the use of Herceptin (trastuzumab), obtained from the National Surgical...

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Breast Cancer, Breast Cancer, Metastatic, Breast Cancer - Adjuvant, Gastric Cancer

Herceptin patient information at Drugs.com