FDA Panel Spurns Approval For AstraZeneca's Ovarian Cancer Drug Olaparib

June 26, 2014 4:02 AM

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A U.S. Food and Drug Administration advisory committee has Wednesday recommended against the accelerated approval for AstraZeneca Plc's (AZN: Quote) ovarian cancer drug olaparib based on mid-stage study results. The FDA Oncologic Drugs Advisory Committee voted 11 to 2 that the current evidence from clinical studies does not support an accelerated approval for use of olaparib.

The investigational drug is indicated as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have the germline BRCA (gBRCA) mutation, and who are in complete or partial response to platinum-based chemotherapy. The sales potential for this drug is reportedly pegged a...

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