EC approves Avastin for NSCLC

The EC approved an MAA from Roche (SWX:ROG) to expand the label of Avastin bevacizumab to include first-line treatment of patients with advanced non-small cell lung cancer in combination with platinum-based chemotherapy.

Separately, Genentech (DNA) resubmitted an sBLA for Avastin plus paclitaxel to treat chemotherapy-naive patients with locally recurrent or metastatic breast cancer. In September 2006, DNA received a complete response letter from FDA requesting additional information from the Phase III E2100 trial, including an independent review of patient scans for progression-free survival (PFS), the trial's primary endpoint. DNA said the results of the independent review are consistent with the interim analysis of the trial that was originally submitted to FDA. DNA said it expects the sBLA to receive a six-month review. ...