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MARCH 29, 2017

FDA Approves Niraparib for Recurrent Ovarian Cancer

By Gina Shaw

The FDA has approved the PARP inhibitor niraparib (Zejula, Tesaro Inc.) for the maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in patients whose tumors have had a complete or partial response to platinum-based chemotherapy. Unlike other PARP inhibitors, niraparib is active in both patients with and without BRCA mutations, according to the agency.

The approval was based on results of the Phase III NOVA trial, which were presented at