FDA Approves Niraparib as Maintenance Treatment in Women with Advanced Ovarian, Fallopian and Primary Peritoneal Cancer Regardless of Biomarker Status

News // Press Releases
May 3, 2020

PRIMA/ENGOT-OV26/GOG-3012 was a randomized phase 3 international placebo controlled trial that enrolled 733 women with newly diagnosed advanced ovarian cancer who were at exceptionally high risk of recurrence. Patients were randomized 2:1 to niraparib versus active surveillance. Niraparib (trade name Zejula) is an orally active small molecule PARP inhibitor developed by Tesaro (now GSK)  to treat ovarian cancer. Niraparib was granted fast track designation by the US Food and Drug Administration (FDA), and Tesaro submitted a new drug application in 2016. It was approved in recurrent ovarian cancer on 27 March 2017 in the US, and has been approved in Europe on 16 November 2017. Now, based on PRIMA, it gained FDA approval on 29 April 2020 for all women that respond to first-line chemotherapy based on the fact that it helped women remain remission longer without effecting the quality of their lives. This new maintenance approval in newly diagnosed patients should be considered in all suitable patients and will undoubtedly impact more women now that it is available earlier.

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