Council Recommendation Goes Against Genentech's Avastin

The Food and Drug Administration’s Oncologic Drugs Advisory Committee voted unanimously on Wednesday to withdraw approval for Genentech’s drug Avastin to be used by patients with metastatic breast cancer.

The FDA proposed removing breast cancer as a viable use for Avastin in December 2010. The drug was first approved for breast cancer use in 2008 under an accelerated approval program. However, the agency has since decided that there was not enough evidence that the drug was safe and effective for use against breast cancer.

However, the council’s vote is merely a recommendation and not the final decision. FDA Commissioner Margaret Hamburg will make the final decision, although no time has been specified.

Genentech and the Center for Drug Evaluation and Research — which first proposed withdrawal of approval of the drug for breast cancer — both have until July 28 to provide additional written submissions.

The council answered the following questions when determining if Avastin should be used by breast cancer patients:

1. Do the AVADO and RIBBON1 trials fail to verify the clinical benefit of Avastin for the breast cancer indication for which it was approved? CDER asked for yes vote, Genentech for no vote. Yes: 6 votes No: 0 votes

2.A. Does the available evidence on Avastin demonstrate that the drug has not been shown to be effective for the breast cancer indication for which it was approved? CDER asked for yes vote, Genentech for no vote. Yes: 6 votes No: 0votes 2.B. Does the available evidence on Avastin demonstrate that the drug has not been shown to be safe for the breast cancer indication for which it was approved, in that Avastin has not been shown to present a clinical benefit that justifies the risks associated with use of the product for this indication? CDER asked for yes vote, Genentech for no vote. Yes: 6 votes No: 0 votes3. If the Commissioner agrees with the grounds for withdrawal set out in issue 1, issue 2.A, or issue 2.B, should FDA nevertheless continue the approval of the breast cancer indication while the sponsor designs and conducts additional studies intended to verify the drug's clinical benefit? Genentech asked for a yes vote, CDER for a no vote. Yes: 0 votes No: 6 votes