Metastatic CRPC: FDA approves rucaparib for previously treated patients with BRCA mutations

  • FDA
  • 15 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 granted accelerated approval to rucaparib for the treatment of patients with BRCA-mutated (germline and/or somatic) metastatic castration-resistant prostate cancer (mCRPC) previously treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
  • The recommended dose is 600 mg twice daily with or without food.
  • Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently, or should have had bilateral orchiectomy.

Why this matters

  • Rucaparib is the first PARP inhibitor to receive approval for patients with mCRPC who harbor a deleterious BRCA mutation.

Key highlights

  • Approval was based on the ongoing TRITON2 trial.
  • 115 previously treated patients with BRCA-mutated mCRPC received rucaparib and concomitant GnRH analog or had prior bilateral orchiectomy.
  • Objective response rate in 62 evaluable patients was 44% (95% CI, 31%-57%).
  • 27 patients had confirmed objective responses, of which 15 had duration of response (DOR) of ≥6 months.
  • Median DOR was not evaluable (95% CI, 6.4 months-not evaluable).
  • The range for DOR was 1.7-24+ months.
  • The most common adverse reactions (≥20%) were fatigue, nausea, anemia, increased aspartate aminotransferase/alanine aminotransferase, decreased appetite, rash, and constipation.

For Prescribing Information, click here