FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Grants Priority Review to Tesaro’s Niraparib

Dec. 29, 2016
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Tesaro was granted Priority Review by the FDA for niraparib in ovarian cancer. Its PDUFA date is set for June 2017.

Niraparib is a PARP inhibitor being evaluated in patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, following response to platinum-based chemotherapy.

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