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3 years ago
FDA staff question validity of benefit seen with AstraZeneca drug
June 23, 2014 / 12:35 PM / 3 years ago

FDA staff question validity of benefit seen with AstraZeneca drug

June 23 (Reuters) - Staff reviewers at the U.S. Food and Drug Administration said AstraZeneca Plc's experimental ovarian cancer drug olaparib showed an 83 percent reduction in the risk of disease progression but questioned whether the result could be reproduced.

The drug, olaparib, is designed as a maintenance treatment for certain women with relapsed ovarian cancer whose tumors are responding completely or in part to platinum-based chemotherapy.

Olaparib blocks the activity of Poly (ADP-ribose) polymerase (PARP), an enzyme that plays a key role in cell repair. The drug is aimed at women with a BRCA gene mutation. Patients in a clinical trial had a seven-month median improvement in progression-free survival.

The staff report, published on the FDA's website on Monday, comes two days ahead of a meeting of outside experts who will discuss whether the drug's benefits outweigh its risks and whether further data is needed before approval. (Reporting by Toni Clarke in Washington; Editing by Bill Trott)

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