ARTICLE | Regulation

Defining meaningful

How ODAC votes on Votrient, Taltorvic set out path for new sarcoma drugs

March 26, 2012 7:00 AM UTC

For the first time in nearly 30 years, sarcoma drug developers have an outline of the profile of an approvable drug. FDA's Oncologic Drugs Advisory Committee last week indicated agents will need to offer an improvement of several months on progression-free survival, a trend toward a survival advantage and a manageable safety profile.

At the same time, ODAC reminded drug developers that statistical significance is not necessarily clinically meaningful as the panel voted down Taltorvic ridaforolimus from Merck & Co. Inc. and Ariad Pharmaceuticals Inc., while Votrient pazopanib from GlaxoSmithKline plc cleared the bar...