GAITHERSBURG, Md. (AP) -- Federal health advisers said overwhelmingly that the Roche drug Avastin's approval for breast cancer should be withdrawn after follow-up studies failed to show meaningful benefits for patients.
A Food and Drug Administration panel of experts voted 12-1 in favor of removing the drug's indication for use in breast cancer patients alongside chemotherapy on Tuesday.
The FDA in 2008 approved Avastin for breast cancer based on a trial showing it significantly lengthened the time until the disease worsened. But two follow-up studies recently completed by Roche failed to show the same ability to delay disease progression.
The FDA is not required to follow the panel's advice, though it often does.