GAITHERSBURG, Md. A Food and Drug Administration advisory committee has voted to recommend limiting use of a Genentech drug for breast cancer, Genentech, part of Swiss drug maker Roche, said Tuesday.
The FDA’s Oncologic Drugs Advisory Committee voted 12-to-1 that use of Avastin (bevacizumab) combined with paclitaxel chemotherapy as a first-line treatment for advanced HER2-negative breast cancer be removed from the drug’s labeling. The committee’s vote does not affect the current availability of the drug, and the FDA is expected to make a final decision in September. The vote also does not affect Avastin’s use for other cancers.
“We are disappointed by the committee’s recommendation and believe Avastin should continue to be an option for women with this incurable disease,” Genentech SVP and global head of clinical development for hematology and oncology Sandra Horning stated. “We will continue to discuss the data from the more than 2,400 women who participated in three phase 3 studies with the FDA.”