FDA Questions Accelerated Approval For AstraZeneca’s Olaparib In Ovarian Cancer

 
• By Sue Sutter

Oncologic Drugs Advisory Committee will consider whether the first-in-class PARP inhibitor should come to market on the basis of Phase II data in a subgroup of patients or await results from an ongoing confirmatory study. Agency cites “uncertainties” about validity and magnitude of effect seen in the Phase II trial.

Whether AstraZeneca PLC’s PARP inhibitor olaparib is worthy of approval in ovarian cancer now or instead should await results from an ongoing confirmatory study is the key question up for debate at FDA’s Oncologic Drugs Advisory Committee meeting June 25.

FDA will ask its advisors to vote on whether efficacy and safety data from a single Phase II study in...

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