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Herceptin FDA Approval History

FDA Approved: Yes (First approved September 25, 1998)
Brand name: Herceptin
Generic name: trastuzumab
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Breast Cancer, Gastric Cancer

Herceptin (trastuzumab) is a HER2/neu receptor antagonist indicated for the treatment of HER2 overexpressing breast cancer and for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Development timeline for Herceptin

DateArticle
Aug  1, 2023Lunit Presents Groundbreaking Study on Predicting Treatment Response by HER2 Analysis in Colorectal Cancer
Jun  3, 2023Trial Shows Potential for Chemotherapy-free Treatment of HER2-positive Early Breast Cancer
Oct 20, 2010Approval FDA Approves Herceptin For HER2-Positive Metastatic Stomach Cancer
Nov 16, 2006Approval FDA Approves Herceptin for the Adjuvant Treatment of HER2-Positive Node-Positive Breast Cancer
Sep 25, 1998Approval Herceptin: Biotechnology Breakthrough In Breast Cancer Wins FDA Approval

See also

Herceptin (trastuzumab) Consumer information

Further information

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