ODAC Again Recommends FDA Withdraw Its Approval of Bevacizumab for Metastatic Breast Cancer

In June 2011, a public hearing was convened to consider an appeal of the December 2010 recommendation by FDA to remove the breast cancer indication for bevacizumab (Avastin). FDA’s recommendation late last year was in accordance with a July 2010 recommendation by the Oncologic Drugs Advisory Committee (ODAC). Following the recent 2-day hearing, ODAC again voted to recommend that FDA reverse its earlier accelerated approval of bevacizumab in combination with paclitaxel for treatment of HER2-negative metastatic breast cancer. A final decision will be made by FDA Commissioner Margaret Hamburg. ■