FDA Approves Niraparib for HRD+ Advanced Ovarian Cancer

October 23, 2019 – The FDA has approved niraparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens, and whose cancer is associated with homologous recombination deficiency (HRD)–positive status. The approval is based on results from the single-arm, phase II QUADRA study (NCT02354586), which showed that niraparib elicited an overall response rate … (leggi tutto)