Avastin bevacizumab regulatory update

Roche disclosed in its 4Q12 earnings that the European Commission approved an expansion of the label of Avastin bevacizumab to include second-line therapy with the cancer drug plus chemotherapy in metastatic colorectal cancer (mCRC) patients who progressed after first-line treatment with Avastin. EMA's CHMP issued a positive opinion for the additional indication last November (see BioCentury, Dec. 3, 2012). FDA approved the humanized mAb against VEGF for the indication last month (see BioCentury, Jan. 28). Avastin is also approved in the U.S. and EU for first- and second-line treatment of mCRC, unresectable or metastatic non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC), as well as for glioblastoma multiforme (GBM) in the U.S. and for first-line treatment of metastatic breast cancer and epithelial ovarian, fallopian tube or primary peritoneal cancer in the EU.

Genentech markets Avastin in the U.S., while Roche markets it elsewhere. Chugai, which is majority owned by Roche, markets Avastin in Japan. ...