FDA Questions Accelerated Approval For AstraZeneca’s Olaparib In Ovarian Cancer
This article was originally published in The Pink Sheet Daily
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.
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