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Frontline Maintenance Niraparib Takes Step Toward EU Approval in Ovarian Cancer

Gina Columbus @ginacolumbusonc
Published: Thursday, Feb 27, 2020

The European Medicines Agency (EMA) has validated a Type II Variation for niraparib (Zejula) as a first-line maintenance treatment for patients with advanced ovarian cancer who have responded to platinum-based chemotherapy, regardless of biomarker status.1

The submission is based on findings from the phase III PRIMA (ENGOT-OV26/GOG-3012) trial, which demonstrated clinically meaningful outcomes with the PARP inhibitor in the frontline maintenance setting in this patient population. In the overall study population, niraparib led to a median progression-free survival (PFS) of 13.8 months compared with 8.2 months in patients who received placebo, leading to a 38% reduction in the risk of disease or progression or death (HR, 0.62; 95% CI, 0.50-0.76; P <.001).2,3

Specifically, in patients whose tumors were positive for homologous recombination deficiency (HRD), the median PFS with niraparib was 21.9 months compared with 10.4 months for placebo (HR, 0.43; 95% CI, 0.50-0.76; P <.001).

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