Genentech appeals FDA's plan to pull Avastin off market
NEW YORK — Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.
The San Francisco Business Times reported Tuesday that Genentech, part of Swiss drug maker Roche, is appealing the FDA’s plan to revoke approval for the drug Avastin (bevacizumab) as a first-line treatment for advanced HER2-negative breast cancer in combination with paclitaxel chemotherapy.
The company submitted the data it plans to use for its appeal hearing with the agency, though a date has not been set, the newspaper reported.
The FDA announced on Dec. 16 that it was planning to revoke Avastin’s approval for the indication after it reviewed four clinical studies and concluded that the drug does not prolong patients’ overall survival or slow the disease’s progression enough to outweigh its “significant risk” to patients. In July, the FDA’s Oncologic Drugs Advisory Committee had voted 12-1 to recommend revoking the approval.