FDA Panel Review Of Merck/Ariad’s Sarcoma Drug Could Hinge On Clinical Significance Of Progression-Free Survival Benefit

The Oncologic Drugs Advisory Committee will review two drugs for sarcoma indications on March 20: Merck/Ariad’s Taltorvic (ridaforolimus) and GlaxoSmithKline’s Votrient (pazopanib). With a three-week median PFS advantage in its pivotal trial, ridaforolimus could face the same questions about clinically significant benefit that led to revocation of Avastin’s metastatic breast cancer claim.

The clinical significance of the progression-free survival benefit seen with Merck & Co. Inc./Ariad Pharmaceuticals Inc.’s investigational sarcoma treatment Taltorvic (ridaforolimus) is likely to be a key discussion point for FDA’s Oncologic Drugs Advisory Committee during its March 20 review of the mTOR inhibitor.

Ridaforolimus was associated with a median PFS benefit of three weeks in its pivotal trial, an advantage that FDA reviewers and ODAC members may look upon skeptically given the recent...

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