FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Grants Priority Review to Tesaro’s Niraparib

Dec. 29, 2016

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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