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.
Archive for July 2010
Last week, an FDA Advisory Committee met to discuss QNEXA, the fixed dose combination drug from Vivus (VVUS) for the treatment of obesity. While it is reported that there was Advisory Committee discussion that favored certain aspects of the drug, overall, the drug was not favorably considered by the committee. The response to this NFC recommendation by the Advisory Committee was reflected in sharp drop in the share price in Vivus, down over 50%. Does the drop in share price suggest that there were some investors actually expecting a positive recommendation by the Advisory Committee? If so, we say why? Did they think that a new fixed dose combination diet preparation could get out of the regulatory shadow cast by phen-fen?