FDA approves first-line maintenance niraparib in ovarian cancer

  • FDA
  • 29 Apr 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • The FDA has approved maintenance niraparib for treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
  • Recommended niraparib doses:
    • Patients weighing
    • Patients weighing ≥77 kg and platelet count ≥150,000/μL: 300 mg once daily.

Why this matters

  • Patients with ovarian cancer have a highly unmet need.
  • Maintenance niraparib can delay progression in selected patients.

Key highlights

  • The approval was based on PRIMA, a double-blind, placebo-controlled trial.
  • 733 patients in a complete or partial response to first-line platinum-based chemotherapy were randomly assigned to niraparib or placebo.  
  • Maintenance niraparib significantly improved PFS in:
    • Patients with homologous recombination-deficiency:
      • Median, 21.9 vs 10.9 months.
      • HR, 0.43 (P<.0001>
    • Overall population: 
      • Median, 13.8 vs 8.2 months.
      • HR, 0.62 (P<.0001>
  • The most common adverse reactions (≥10%) were thrombocytopenia, anemia, nausea, fatigue, neutropenia, constipation, musculoskeletal pain, leukopenia, headache, insomnia, vomiting, dyspnea, decreased appetite, dizziness, cough, hypertension, liver enzyme elevation, and acute kidney injury.

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