FDA Panel Votes Against Accelerated Approval of AstraZeneca Ovarian Cancer Drug


By Razak Musah Baba

LONDON--AstraZeneca PLC (AZN.LN) said Thursday the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee voted against accelerated approval of investigational ovarian cancer drug olaparib.

AstraZeneca said the FDA advisory committee voted 11 to 2 that current evidence from clinical studies don't support accelerated approval of olaparib "as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have the germline BRCA mutation, and who are in complete or partial response to platinum-based chemotherapy."

In a statement, Briggs Morrison, AstraZeneca's global medicines development and chief medical officer, said the company was disappointed with the recommendation.

He said, we "strongly believe that olaparib has the potential to provide patients with relapsed BRCA-mutated ovarian cancer and their doctors with a much-needed treatment option. In the meantime, we are continuing with our Phase III clinical program to evaluate the benefit of olaparib for this patient population. We aim to have completed this study by the end of 2015."

The ODAC provides the FDA with independent, expert advice and recommendations, however the final decision regarding approval is made by the FDA.

AstraZeneca said olaparib inhibits a key enzyme that is active in cell repair to selectively induce cancer cell death.

Write to Razak Musah Baba at razak.baba@wsj.com; Twitter: @Raztweet

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