ARTICLE | Clinical News

Niraparib regulatory update

December 27, 2016 5:15 PM UTC

FDA accepted and granted Priority Review to an NDA from Tesaro for niraparib to treat recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer following response to platinum-based chemotherapy. Its PDUFA date is June 30. Tesaro said FDA does not plan to hold an advisory committee meeting to discuss the oral PARP inhibitor. Tesaro based the submission on data from the Phase III NOVA trial in which niraparib met the primary endpoint of improving progression-free survival (PFS). The trial evaluated niraparib as maintenance therapy in platinum-sensitive ovarian cancer patients with and without germline breast cancer early onset (BRCA) mutations (see BioCentury, Oct. 17, 2016)...

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Merck & Co. Inc.

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