FDA approves olaparib first-line maintenance therapy for ovarian cancer


  • Deepa Koli
  • Oncology drug update
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Takeaway

  • The FDA has approved olaparib maintenance treatment in adult patients with deleterious or suspected deleterious germline/somatic BRCA+ advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
  • Recommended dose is 300 mg twice daily, with or without food.
  • The FDA also approved ­­­­BRACAnalysis CDx test to identify patients with germline BRCA-mutation eligible for olaparib.

Why this matters

  • Advanced ovarian cancer has poor prognosis.

Key highlights

  • Approval was based on the double-blind, placebo-controlled SOLO-1 trial.
  • 391 patients were randomly assigned 2:1 to receive olaparib (n=260) or placebo (n=131).
  • Olaparib was associated with significantly longer investigator-assessed median PFS (not reached vs 13.8 months; HR, 0.30; P<.0001 vs placebo.>
  • OS data were not mature.
  • Most common adverse events (≥10%) with olaparib were nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia, decreased appetite, dizziness, neutropenia, dyspepsia, dyspnea, urinary tract infection, leukopenia, thrombocytopenia, and stomatitis.
  • Deleterious germline BRCA mutation was identified using ­­­­BRACAnalysis CDx test in SOLO-1.

Prescribing Information, click  here .