FDA approves olaparib for HRR-mutated prostate cancer

  • FDA
  • 19 May 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • The FDA has approved olaparib for treatment of adult patients with deleterious or suspected deleterious germline/somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who experienced progression during enzalutamide/abiraterone treatment.
  • The agency also approved companion diagnostic test FoundationOne CDx for selection of patients with mCRPC carrying HRR gene alterations and the BRACAnalysis CDx test for selection of patients carrying germline BRCA1/2 alterations.
  • The recommended dose is 300 mg twice daily.

Why this matters

  • Olaparib is the new standard of treatment for patients who have progressed after enzalutamide/abiraterone treatment.

Key highlights

  • The approval was based on PROfound, an open-label, multicenter, phase 3 trial.
  • 387 patients were randomly assigned 2:1 to olaparib or investigator’s choice of enzalutamide or abiraterone acetate.
  • In the cohort with BRCA1/2 or ATM mutations (n=245), olaparib significantly improved:
    • Radiographic PFS:
      • Median, 7.4 vs 3.6 months.
      • HR, 0.34 (P<.0001>
    • OS:
      • Median, 19.1 vs 14.7 months.
      • HR, 0.69 (P=.0175).
    • Objective response rate:
      • 33% vs 2% (P<.0001>
  • Olaparib prolonged radiographic PFS in the overall population: 5.8 vs 3.5 months (HR, 0.49; P<.0001>
  • Anemia, nausea, fatigue, and decreased appetite were the most common adverse events in the olaparib group.
  • Venous thromboembolic events were more common with olaparib (7% vs 3.1%).

For Prescribing Information, click here.