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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.



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