FDA Sets Feb. 5 Date for Avastin’s Colon Cancer sBLA

The FDA has granted a priority review to Genentech’s sBLA for Avastin in people with metastatic colorectal cancer (mCRC) who have already been treated with chemotherapy plus Avastin. The agency aims to finish its review by Feb. 5. Genentech’s filing is based on a first-of-its-kind prospective Phase III study that evaluated continually inhibiting vascular endothelial growth factor as a potential treatment strategy for mCRC, the Roche subsidiary said Oct. 16.
Washington Drug Letter