- 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.
- 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 .