BioCentury
ARTICLE | Clinical News

Avastin bevacizumab regulatory update

October 29, 2012 7:00 AM UTC

Roche said in its 3Q12 earnings that in October FDA granted Priority Review to an sBLA from its Genentech unit for Avastin bevacizumab in combination with 5-FU-based chemotherapy as second-line therapy for metastatic colorectal cancer (mCRC) in patients who progressed on first-line therapy with an Avastin-containing regimen. Avastin plus 5-FU-based chemotherapy is approved in the EU and U.S as first-line treatment of mCRC and as second-line treatment of mCRC in patients who had not previously received Avastin. The pharma said it submitted worldwide applications for the indication in 3Q12. ...