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

This article was originally published in The Pink Sheet Daily

Executive Summary

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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