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No accelerated approval for olaparib

  • The FDA's Oncologic Drugs Advisory Committee votes 11-2 in favor of requiring AstraZeneca (AZN +0.9%) to submit additional clinical data demonstrating the efficacy of olaparib as a treatment for ovarian cancer before it will consider recommending approval. The panel's opinion was that the data the company submitted in its application was not robust enough to prove it could be reproduced. Committee members also voiced concern about a potential risk of secondary cancers in patients receiving the drug.
  • The vote means that regulatory clearance will not happen until at least 2016.
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