Genentech Fails to Sway FDA Panel
An FDA advisory panel voted 12-1 today against the usage of Genentech’s bevacizumab (Avastin) as a treatment for women with certain forms of breast cancer. The Oncologic Drugs Advisory Committee recommended that the FDA remove language from the drug’s prescribing information that states it can be used for women getting their first round of treatment for breast cancers that don’t have overexpressed forms of a protein called HER2. The FDA’s deadline to make its decision on the matter is Sept. 17. While the agency doesn’t always follow the advice of its panels, it usually does. “We are disappointed by the committee’s recommendation and believe Avastin should be an option for women with this incurable disease,” said Sandra Horning, a Genentech senior vice president, in a statement. Avastin is currently approved by the FDA to treat lung, colorectal, brain, kidney, and breast cancers.