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How ODAC votes on Votrient, Taltorvic set out path for new sarcoma drugs
Defining meaningful
By Michael Flanagan
Senior Writer
Published on
Monday, March 26, 2012
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.
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