www.fdanews.com/articles/179837-fda-grants-priority-review-to-tesaros-niraparib
FDA Grants Priority Review to Tesaro’s Niraparib
December 28, 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.