GSK's Votrient Clears ODAC Despite Outdated Trial, FDA Safety Concerns
FDA might not always demand that a new oncologic be compared to the current standard of care if its trial was conducted before that standard was established, Office of Oncology Drug Products Director Richard Pazdur said at an Oct. 5 advisory committee meeting
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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 sixth drug approved to treat renal cell carcinoma, Votrient wins approval just two weeks after a unanimous endorsement from FDA's Oncologic Drugs Advisory Committee.
The panel voted 6-4 to recommend approval of the sBLA for PegIntron (peginterferon alfa-2b) for melanoma, and unanimously for Glaxo's Votrient (pazopanib) for advanced renal cell carcinoma.