ARTICLE | Clinical News

Avastin bevacizumab regulatory update

May 16, 2011 7:00 AM UTC

FDA posted a Federal Register notice outlining the issues to be discussed at a June 28-29 hearing about the proposed withdrawal of metastatic breast cancer from the label of Avastin bevacizumab from Roche's Genentech unit. The panel will consider whether the Phase III AVADO and RIBBON1 trials "fail to verify the clinical benefit" of Avastin for the breast cancer indication, as well as whether available evidence demonstrate that Avastin "has not been shown" to be safe and effective for the breast cancer indication. If the FDA commissioner agrees that the data provide grounds for withdrawal, the panel will also discuss whether FDA should allow the humanized mAb against VEGF to remain approved for breast cancer while Genentech designs and conducts additional studies to verify Avastin's clinical benefit.

FDA indicated that the hearing will now include 2 hours for oral public comment; previously, FDA had planned to accept public comments in writing only. The deadline for FDA's Center for Drug Evaluation and Research and Genentech to submit their respective argument summaries is May 13. ...