US FDA accepts supplemental new drug application for niraparib as first line maintenance treatment of ovarian cancer

The application is based on data from the PRIMA phase III RCT which met its primary endpoint of a statistically significant improvement in progression-free survival (compared to placebo) for women regardless of their biomarker status.

SPS commentary:

Niraparib is currently only licensed as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.


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