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FDA Accepts Niraparib Application for Frontline Maintenance in Ovarian Cancer

Jason M. Broderick @jasoncology
Published: Monday, Feb 24, 2020

The FDA has accepted a supplemental New Drug Application (sNDA) for niraparib (Zejula) for use as a frontline maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.1

The application is based on findings from the phase III PRIMA study (ENGOT-OV26/GOG-3012), in which frontline maintenance therapy with niraparib improved median progression-free survival (PFS) by 5.6 months compared with placebo for patients with newly diagnosed, advanced ovarian cancer who responded to platinum-based chemotherapy.2,3

In the overall population of the PRIMA study, the median PFS in the niraparib arm was 13.8 months compared with 8.2 months in the placebo group, representing a 38% reduction in the risk of progression or death with the addition of the PARP inhibitor (HR, 0.62; 95% CI, 0.50-0.76; P <.001). In patients with tumors that tested positive for homologous recombination deficiency (HRD), the median PFS was 21.9 months with niraparib compared with 10.4 months for placebo (HR, 0.43; 95% CI, 0.50-0.76; P <.001).

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