FDA's ODAC recommends withdrawal of Avastin approval for metastatic breast cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that, during a U.S. Food and Drug Administration (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.

"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.