New Phase III trial results show positive and durable treatment effect of niraparib

13 March 2017

Positive secondary endpoint results from the Phase III ENGOT-OV16/NOVA trial of niraparib have been presented at the 2017 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer by Dr Sven Mahner, director, Department of Gynecology and Obstetrics, University of Munich.

Niraparib is being developed by oncology-focussed US biotech firm Tesaro (Nasdaq: TSRO), which earlier this year launched a managed access program in the USA for its investigational cancer treatment. The company’s New Drug Application for the drug has been accepted for priority review by the US Food and Drug Administration. The FDA granted priority review for the niraparib NDA and established a Prescription Drug User Fee Act (PDUFA) goal date of June 30, 2017.

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