Avastin bevacizumab regulatory update

EMA's CHMP concluded its reexamination of its May negative opinion and reiterated its recommendation against expanding the label of Avastin bevacizumab to include treatment of newly diagnosed glioblastoma in combination with radiotherapy and temozolomide. The agency said it still believed there is insufficient demonstration of Avastin's efficacy (see BioCentury, June 2).

The humanized mAb against VEGF has accelerated approval in the U.S. and is approved in over 60 countries worldwide to treat glioblastoma in patients with progressive disease following prior therapy. Avastin is approved in the EU and U.S. for metastatic colorectal cancer (mCRC), unresectable or metastatic non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC). Avastin is also approved in the EU for epithelial ovarian, fallopian tube or primary peritoneal cancer and first-line treatment of HER2-negative metastatic breast cancer. ...