FDA approves supplemental NDA for Zejula in epithelial ovarian, fallopian tube or primary peritoneal cancer.- GlaxoSmithKline

The FDA has approved GlaxoSmithKline's supplemental New Drug Application (sNDA) for Zejula (niraparib) as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status. Until now, only 20% of women with ovarian cancer, those with a BRCA mutation (BRCAm), were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting.This new indication is supported by data from the phase III PRIMA study (ENGOT-OV26/GOG-3012), which enrolled patients with newly diagnosed advanced ovarian cancer following a complete or partial response to platinum-based chemotherapy regardless of biomarker status. The PRIMA study significantly improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula resulted in a 57% reduction in the risk of disease progression or death vs. placebo (HR 0.43; 95% CI, 0.31 to 0.59; p<0.0001), and a 38 reduction in the risk of disease progression or death vs. placebo in the overall population hr 0.62 95 ci 0.50 to 0.76 p><0.0001). zejulas safety profile as demonstrated by the prima results was consistent with clinical trial experience. the most common grade 3 or higher adverse events with zejula included thrombocytopenia 39 anaemia 31 and neutropenia 21.>