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FDA Approves Niraparib for HRD+ Advanced Ovarian Cancer

Gina Columbus @ginacolumbusonc
Published: Wednesday, Oct 23, 2019

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, and whose cancer is associated with homologous recombination deficiency (HRD)–positive status.1

The approval is based on results from the single-arm, phase II QUADRA study (NCT02354586), 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).2 The estimated median duration of response was 8.3 months (95% CI, 6.5–not estimable). 

HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression ≥6 months after response to the last platinum-based chemotherapy. Simultaneously with the niraparib approval, the FDA also approved the Myriad myChoice companion diagnostic assay to determine HRD-positive status in patients with advanced ovarian cancer who are eligible to receive niraparib in the late-line treatment setting.

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