June 29, 2011, 2:56 PM
F.D.A. Panel Rejects Use of Avastin for Breast Cancer
By ANDREW POLLACK
Updated:
An advisory committee to the Food and Drug Administration voted unanimously on Wednesday that the approval of Avastin as a treatment for breast cancer should be revoked, despite a two-day appeal hearing by Genentech, the drug’s manufacturer.
In four 6-0 votes, the committee said recent studies have not shown that the drug is safe and effective. It unanimously rejected a compromise proposal made by Genentech that the approval be retained while the company conducts another clinical trial to confirm that the drug works.
The votes make it more likely that the F.D.A. will go ahead with its decision, made in December, to rescind the approval. The actual decision will be made by the agency’s commissioner, Dr. Margaret A. Hamburg. It is not clear when the decision will be made but it will not be until after July 28 because the F.D.A. will still accept public comments until then.
The votes came after an emotional two-day hearing at the F.D.A. campus in Silver Spring, Md., in which about a dozen women with breast cancer, many of them saying that Avastin was helping control their disease, pleaded with the agency to make sure the drug remained available. Read more…
