FDA advisory committee votes to revoke approval of bevacizumab (Avastin®) for metastatic breast cancer patients

July 20, 2010

The FDA Oncologic Drugs Advisory Committee (ODAC) voted 12 to 1 to recommend that FDA revoke the approval of bevacizumab (Avastin®) as a first-line treatment for HER2-negative metastatic breast cancer. ODAC voted that the results of the AVADO and RIBBON 1 trials did not confirm the magnitude of meaningful clinical benefit as shown in the earlier E2100 study results.  The panel voted to remove the indication of bevacizumab for breast cancer.