FDA Grants Hearing on Withdrawal of Bevacizumab Approval


The Food and Drug Administration has granted Genentech a 2-day hearing on the agency’s plan to strip bevacizumab of accelerated approval for the treatment of metastatic breast cancer, the company announced on Feb. 24.

Genentech, a member of the Roche group, has appealed the proposed withdrawal of the indication for bevacizumab (Avastin) in combination with paclitaxel (Taxol) as a first-line treatment of HER2-negative metastatic breast cancer. The decision was based on the failure of a follow-up study to confirm a progression-free survival benefit for the regimen. It followed a near-unanimous recommendation favoring withdrawal by the FDA’s Oncologic Drugs Advisory Committee, which expressed concern about risks associated with treatment.

In 2008, bevacizumab received the accelerated approval for the metastatic breast cancer indication; conversion to full approval was contingent on the confirmation of benefit in follow-up studies. It is approved for other indications, so the drug itself is not being taken off the market.

The hearing is scheduled for June 28-29, 2011. "We appreciate the opportunity to continue our discussion with the FDA during a public hearing about the use of Avastin in metastatic breast cancer," Dr. Hal Barron, chief medical office and head of Global Product Development at Genentech said in the company statement.