US FDA lawyers urge no 'do-over' for Avastin breast cancer indication
This article was originally published in Scrip
Executive Summary
Unwilling to roll over just yet, Roche unit Genentech made a last-ditch effort to try to save its HER2-negative metastatic breast cancer (MBC) indication for Avastin (bevacizumab), pleading with the US FDA to accept what the firm called its "middle-ground" proposal, which includes a new confirmatory Phase III trial, a risk evaluation and mitigation strategy (REMS) plan and restricting the drug in combination with paclitaxel to only patients with aggressive disease.