SAFETY ALERT: FDA Update on Avastin for Metastatic Breast Cancer

Genentech announced that during a FDA hearing, the FDA's Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA withdraw its approval of Avastin (bevacizumab) in combination with paclitaxel chemotherapy for previously untreated, first-line HER2-negative metastatic breast cancer. The committee's recommendation is not the final decision and Avastin plus paclitaxel is still FDA approved for women with HER2-negative metastatic breast cancer. The FDA Commissioner will make the final decision on whether Avastin should remain approved for metastatic breast cancer. The FDA has not announced when the Commissioner will make the final decision.

Until the FDA Commissioner makes the final decision, Avastin remains FDA approved for use in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer in the United States. The effectiveness of Avastin in HER2-negative metastatic breast cancer is based on an improvement in progression-free survival (PFS) in the E2100 study. There is no data available showing that Avastin improves disease-related symptoms or survival in HER2-negative metastatic breast cancer.

Avastin is a biologic antibody designed to specifically bind to vascular endothelial growth factor (VEGF), a protein that plays an important role in angiogenesis. It interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells.

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