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# GSK Narrows Zejula Indication at FDA’s Request
- URL: https://www.fdaweb.com/gsk-narrows-zejula-indication-at-fdas-request/
- Published: 2022-11-11T12:00:00.000Z
- Updated: 2026-09-14T18:06:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153184

GSK says it has complied with an FDA request to restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious germline BRCA mutations (g*BRCA*mut). The first-line indication remains unchanged for maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy, it says.

The narrowed indication comes after an agency review of the final overall survival (OS) analysis of the ENGOT-OV16/NOVA Phase 3 trial, which the company says served as the basis for the approval of the second-line maintenance indication. In the final OS results from this trial, the “secondary endpoint of OS demonstrated a hazard ratio (HR) of 1.06 (95% CI: 0.81-1.37) in the non-g*BRCA*mut cohort,” it says. “The primary endpoint of the NOVA study was progression-free survival (PFS), evaluated as two independently powered cohorts (g*BRCA*mut and non-g*BRCA*mut); results demonstrated the clinically meaningful and statistically significant benefit of niraparib in both cohorts and across the HRD \[homologous recombination deficiency\] subgroups in the non-gBRCAmut cohort."

GSK adds that it is in ongoing discussions about these and other emerging OS data with health authorities worldwide.