FDA Advisory Committee Recommends to Withdraw Avastin Approval

The recommendation of the FDA's Oncologic Drugs Advisory Committee is not the final decision. Avastin plus paclitaxel is still FDA approved for women with HER2-negative metastatic breast cancer.

Roche announced 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.

"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 He