FDA Grants Hearing To Appeal Avastin Breast Cancer Withdrawal
This article was originally published in The Pink Sheet Daily
Genentech and FDA will argue over revoking the accelerated approval for breast cancer before ODAC, which voted to remove the indication last July.
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In a sign of the uphill battle Genentech faces in retaining Avastin’s breast cancer claim, the company’s efforts to shape the panel and format for a June 28-29 hearing on the indication’s withdrawal are encountering strong opposition from FDA’s Center for Drug Evaluation & Research.