Zejula regulatory update

FDA approved an NDA for Zejula niraparib from Tesaro as maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer following response to platinum-based chemotherapy. Tesaro plans to disclose the oral PARP inhibitor's price close to launch, likely in late April. The approval comes more than 3 months ahead of Zejula's June 30 PDUFA date.

Zejula's label does not require breast cancer early onset (BRCA) mutation or biomarker testing. Data presented last October from the Phase III NOVA trial suggested that Zejula could be approved to treat ovarian cancer regardless of a patient's gene mutation status (see BioCentury, Oct. 17, 2016)...