AVASTIN – The next surprise?

On July 20, 2010, an FDA Advisory Committee will evaluate and discuss new data submitted by Roche for the use of Avastin in advanced breast cancer.  FDA granted Roche an accelerated approval under which Roche was to complete additional studies to confirm a survival benefit.  The FDA review indicates that these new studies don’t confirm the survival benefit seen in the first study.  This Advisory Committee debate should result in an NFC recommendation to the FDA.  Will the FDA allow the approval for advanced cancer to remain in the label?  We doubt it – the studies failed the regulatory hurdle established.  If they do, the indication will probably have significant limitations.  Regardless of the outcome of the Advisory Committee discussions and the final FDA action, the drug will still be available as it has multiple approved indications for use in the US.