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FDA committee to discuss olaparib

April 18, 2014 10:45 PM UTC

FDA's Oncologic Drugs Advisory Committee will meet on June 25 to discuss an NDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) for olaparib as maintenance treatment of platinum-sensitive relapsed ovarian cancer. The pharma said it submitted the NDA this year, but declined to disclose when it did so or the PDUFA date. The poly(ADP-ribose) polymerase (PARP) inhibitor is also under review in Europe.

The NDA covers use of olaparib in patients with germline breast cancer early onset (BRCA) mutation as detected by an FDA-approved test. Earlier this month, Myriad Genetics Inc. (NASDAQ:MYGN) submitted to FDA the first of four modules of a PMA for BRACAnalysis test as a companion diagnostic for olaparib. ...