ARTICLE | Clinical News

Avastin bevacizumab regulatory update

September 20, 2010 7:00 AM UTC

FDA extended the PDUFA date for a pair of sBLAs from Genentech for Avastin bevacizumab for the first-line treatment of HER2-negative metastatic breast cancer to Dec. 17 from Sept. 17. The Roche unit said it submitted additional information, which the agency deemed a major amendment. The company is seeking to convert Avastin's accelerated approval in the indication to regular approval, and to expand the label to include combination with docetaxel, anthracycline or capecitabine. The accelerated approval, granted in 2008, already includes combination with paclitaxel. ...