UPDATE: Roche: Genentech Provides Update from FDA Hearing on Avastin for Metastatic Breast Cancer

Genentech, a member of the Roche Group RHHBY, announced today that, during a U.S. Food and Drug Administration (FDA) hearing, the FDA's Oncologic Drugs Advisory Committee recommended that the FDA withdraw its approval of Avastin 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. “We are very disappointed by the committee's recommendation and hope the Commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.” These proceedings and the ODAC's recommendation have no impact on Avastin's approved uses for other cancer types in the United States or the use of Avastin for metastatic breast cancer in other countries. Information for Patients and Physicians 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 are no data available showing that Avastin improves disease-related symptoms or survival in HER2-negative metastatic breast cancer. Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease.