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# GSK sNDA for Zejula as Ovarian Cancer Maintenance
- URL: https://www.fdaweb.com/gsk-snda-for-zejula-as-ovarian-cancer-maintenance/
- Published: 2020-02-24T12:00:00.000Z
- Updated: 2026-09-14T16:04:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146160

FDA has accepted for review a GlaxoSmithKline supplemental NDA for Zejula (niraparib) as a first-line maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. The submission is supported by data from the Phase 3 PRIMA study, which the company says demonstrated clinically-meaningful outcomes niraparib’s use in the first-line maintenance setting. Zejula is currently approved as a maintenance treatment for women with recurrent ovarian cancer who had a response to platinum-based chemotherapy regardless of BRCA mutation status. It is also approved for women with advanced ovarian cancer who have had three or more chemotherapy regimens.