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FDA Approves Niraparib for HRD-Positive Advanced Ovarian Cancer

Oncology Practice Insider

On October 23, 2019, the Food and Drug Administration approved niraparib (ZEJULA®, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy. Read more.