FDA Panel Advises Against Bevacizumab for Breast Cancer

Panel determines that risks outweigh benefits in advanced breast cancer

WEDNESDAY, July 21 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel has recommended that bevacizumab (Avastin) not be used to treat patients with advanced breast cancer, based on lacking evidence of survival benefits.

The panel voted 12 to one that the drug's approval for breast cancer along with chemotherapy should be reversed. The recommendation specifically focused on the drug's breast cancer indication. Bevacizumab is also an approved treatment for colon, lung, brain, and kidney cancers.

Bevacizumab was given accelerated approval for use as a breast cancer treatment in early 2008 based on the requirement that the manufacturer, Roche's Genentech Inc. unit, provide further evidence of survival benefit. However, two follow-up studies failed to demonstrate meaningful benefit and the FDA panel voted unanimously that the drug's adverse event profile and associated risks outweigh its efficacy in this capacity. While the FDA is not required to follow its advisory board recommendations, it usually does.

"We are disappointed by the committee's recommendation and believe Avastin should continue to be an option for women with this incurable disease," Sandra Horning, M.D., senior vice president and global head of Clinical Development Hematology/Oncology at Genentech, said in a statement. "We will continue to discuss the data from the more than 2,400 women who participated in three Phase III studies with the FDA. This recommendation does not impact Avastin's approved uses for other cancer types."

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