CDER Says Keeping Avastin Breast Cancer Claim Would Undermine Accelerated Approval Process

This article was originally published in The Pink Sheet Daily

16 May 2011
News

Sue Sutter @PinkSheetSutter sue.sutter@informa.com

Executive Summary

FDA's Center for Drug Evaluation and Research intends to argue at a June hearing that the accelerated approval system will operate as a lower standard if bevacizumab's breast cancer indication is maintained while Genentech conducts another confirmatory trial.

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CDER Says Keeping Avastin Breast Cancer Claim Would Undermine Accelerated Approval Process

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