Avastin bevacizumab regulatory update

Roche said it submitted an sBLA to FDA on July 16 for Avastin bevacizumab in combination with chemotherapy for second-line treatment of metastatic HER2-negative breast cancer based on data from the Phase III RIBBON2 trial (see BioCentury, Dec. 21, 2009 & Aug. 24, 2009). Last week, FDA's Oncologic Drugs Advisory Committee voted 12-1 to recommend removing the first-line treatment of HER2-negative metastatic breast cancer indication from the label of the humanized mAb against VEGF. ...