FDA Accepts sNDA for Niraparib in First-Line Maintenance Treatment of Ovarian Cancer
Posted: Monday, March 2, 2020
On February 24, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) for the PARP inhibitor niraparib as a first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of BRCA mutation status. It is currently approved in the United States as a maintenance treatment for women with advanced ovarian cancer following three or more chemotherapy regimens.
The application is supported by data from the phase III PRIMA clinical trial (ENGOT-OV26/GOG-3012) presented simultaneously at the 2019 European Society for Medical Oncology Congress and published in The New England Journal of Medicine. This double-blind study assessed the efficacy of niraparib as first-line maintenance therapy in 733 women with newly diagnosed advanced (stage III or IV) ovarian cancer after a response to first-line platinum-based chemotherapy. Half of the patients had tumors with homologous-recombination deficiency.
The study met its primary endpoint: patients who received niraparib had significantly longer progression-free survival than those who received placebo, regardless of the absence or presence of homologous-recominbation deficiency. At a 24-month interim analysis, the rate of overall survival favored niraparib as well (84% vs. 77%). The most common adverse events of grade 3 or higher were anemia (31%), thrombocytopenia (28.7%), and neutropenia (12.8%). No treatment-related deaths were reported.