FDA approves niraparib for heavily pretreated HRD+ ovarian cancer

  • FDA
  • 23 Oct 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • The FDA approved niraparib in patients with homologous recombination deficiency (HRD)-positive advanced ovarian, fallopian tube, or primary peritoneal cancer treated with ≥3 prior chemotherapy regimens.
  • The recommended dose is 300 mg once daily, with/without food.
  • Myriad myChoice CDx test for determination of tumor HRD status to identify patients eligible for niraparib was also approved.

Why this matters

  • Treatment of recurrent ovarian cancer remains challenging.

Key highlights

  • Approval was based on multicenter, phase 2, single-group QUADRA study.
  • 98 patients with advanced ovarian cancer with HRD-positive tumors who had received ≥3 prior lines of chemotherapy were treated with niraparib.
  • HRD-positive status was determined using the Myriad myChoice CDx as tumor BRCA mutated (tBRCAm) (n=63) and/or a genomic instability score ≥42 (n=35).
  • The objective response rate (ORR) was 24% (95% CI, 16%-34%).
  • Estimated median duration of response was 8.3 (95% CI, 6.5-not estimable) months.
  • ORR in patients with tBRCAm ovarian cancer:
    • Platinum-sensitive disease, 39% (95% CI, 17%-64%).
    • Platinum-resistant disease, 29% (95% CI, 11%-52%).
    • Platinum-refractory disease, 19% (95% CI, 4%-46%).
  • 73% of patients reported toxicity-related dose reduction/interruption.
  • Most common adverse reactions resulting in dose reduction or interruption: thrombocytopenia (40%), anemia (21%), neutropenia (11%), nausea (13%), and vomiting (11%).

For Prescribing Information, click here.

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