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Avastin breast cancer "complete response"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Less than four months after Genentech's submission of an sBLA for use of Avastin (bevacizumab) in metastatic breast cancer, FDA issues a "complete response" letter Sept. 8. The agency requested more information related to the use of progression-free survival as a primary endpoint for the company's pivotal trial sponsored by the National Cancer Institute. Specifically, FDA asked for substantial safety and efficacy updates from the trial, including an independent review of patient scans for progression-free survival. Genentech indicated that the scope of the request was more than it had anticipated and may set the approval back more than a year than the firm had projected...
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