ROCHE: FDA a un paso de revocar aprobación de Avastin

By Molly Peterson and Dermot Doherty - Jul 20, 2010

Roche Holding AG’s top-seller Avastin may shed $1 billion in annual revenue if U.S. regulators follow a panel recommendation to revoke approval of the drug for use in breast cancer.

Scientific advisers to the Food and Drug Administration voted 12-1 yesterday to rescind Avastin’s clearance in breast cancer after finding the drug paired with chemotherapies didn’t work better than other medicines alone. The agency usually follows panels’ advice, though it isn’t required to do so.