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Data for Niraparib FDA approval

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"The FDA has approved niraparib (Zejula) for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 3 prior chemotherapy regimens, andwhose cancer is associated with homologous recombination deficiency (HRD)positive status.1 The approval is based on results from the phase II QUADRA study, which showed that niraparib elicited an overall response rate (ORR) of 24% (95% CI, 16-34), which was comprised of all partial responses, in the primary efficacy population of patients who had HRD and who received 3 prior lines of therapy (n = 98).2The estimated median duration of response was 8.3 months (95% CI, 6.5not estimable).HDR was defined by either a deleterious or suspected deleteriousBRCAmutation, or genomic instability in patients with disease progression 6 months after response to the last platinum-based chemotherapy." https://www.oncnursingnews.com/web-exclusives/fda-approves-niraparib-for-patients-with-hrd-advanced-ovarian-cancer