GLAXOSMITHKLINE — Zejula FDA Review (NDA/BLA 214876, 2025)
GSK plc · 2025 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA review of GlaxoSmithKline's sNDA for Zejula (niraparib) in advanced ovarian cancer maintenance treatment, based on final PRIMA trial overall survival (OS) data, led to a recommendation to narrow the indication. Due to a lack of OS benefit and potential detriment in homologous recombination deficiency (HRD)-negative/not determined populations, alongside known safety concerns, the FDA requested the indication be restricted to only HRD-positive tumors. The updated labeling reflects this narrowed indication, incorporating changes to adverse event reporting for MDS/AML and dosage modifications for HRD-positive patients.
Key findings — cited to the page
| PFS 95% CI lower bound (overall population) | 0.50 | PRIMA · p.3 |
| PFS 95% CI upper bound (overall population) | 0.76 | PRIMA · p.3 |
| PFS p-value (HRD-positive) | <0.0001 | PRIMA · p.8 |
| Number of patients randomized (PRIMA) | 733 | PRIMA (Study PR-30-5017-C) · p.2 |
| Niraparib arm patients (PRIMA) | 487 | PRIMA (Study PR-30-5017-C) · p.2 |
| Placebo arm patients (PRIMA) | 246 | PRIMA (Study PR-30-5017-C) · p.2 |
| PFS HR (HRD-positive population) | 0.43 | PRIMA · p.3 |
| PFS 95% CI lower bound (HRD-positive population) | 0.31 | PRIMA · p.3 |
| PFS 95% CI upper bound (HRD-positive population) | 0.59 | PRIMA · p.3 |
| PFS p-value (HRD-positive population) | <0.0001 | PRIMA · p.3 |
| PFS HR (overall population) | 0.62 | PRIMA · p.3 |
| PFS p-value (overall population) | <0.0001 | PRIMA · p.3 |
Source: GSK plc ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →