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Oncology Learning NetworkOlaparib Plus Abiraterone and Prednisone Granted FDA Approval for BRCA-Mutated Prostate Cancer

The FDA approval was granted on May 31, 2023.

The FDA has given its approval to a novel treatment regimen for metastatic castration-resistant prostate cancer (mCRPC) with BRCA mutations. The combination of olaparib, abiraterone acetate, and prednisone is based on the promising results of the phase 3 PROpel trial.

Key Points:

  • The PROpel trial enrolled 796 patients with mCRPC, who had not received prior systemic therapy for metastatic castration-resistant disease.
  • Patients were randomized to receive abiraterone acetate plus prednisone and either olaparib or placebo.
  • The primary efficacy end point was radiological progression-free survival (rPFS) with overall survival (OS) as a secondary end point.

Additional Points:

  • In the subgroup of patients with BRCA mutations (n = 85), the median rPFS was not reached in the olaparib arm, compared to 8 months in the placebo arm (HR: 0.24; 95% CI, 0.12 to 0.45).
  • The OS HR for BRCA mutated patients was 0.30.
  • The most common adverse events in patients receiving olaparib were anemia, fatigue, nausea, diarrhea, decreased appetite, lymphopenia, dizziness, and abdominal pain.
  • 18% of patients required at least one blood transfusion, with 12% requiring multiple transfusions.


  • The combination of olaparib, abiraterone acetate, and prednisone shows significant promise in improving rPFS and OS in patients with BRCA-mutated mCRPC, marking a potential shift in the treatment paradigm.

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Did You Know?
According to the American Cancer Society, approximately 1 in 8 men will be diagnosed with prostate cancer during his lifetime, making it the second most common cancer among men in the United States.

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