FDA Grants Regular Approval to Rucaparib in Metastatic CRPC

Rucaparib (Rubraca) has been granted regular FDA approval as a treatment for adult patients with deleterious BRCA mutation–associated metastatic castration-resistant prostate cancer (CRPC) who received previous androgen receptor-directed therapy, according to a news release from the agency.¹

Findings supporting the regulatory decision come from the open-label phase 3 TRITON3 trial (NCT02975934), which evaluated rucaparib or physician's choice androgen receptor pathway inhibitor (ARPI). Patients were randomly assigned 2:1 to receive the aforementioned agents, and stratification factors included performance status, presence of hepatic metastases, and type of mutation.

Therein, the investigational agent displayed significantly improved radiographic progression-free survival (rPFS) among patients with BRCA-mutated disease. In patients with BRCA mutations treated with rucaparib, the median rPFS was 11.2 months (95% CI, 9.2-13.8) vs 6.4 (95% CI; 5.4-8.3) with physician's treatment of choice (HR, 0.50; 95% CI, 0.36-0.69; P <.0001). Additionally, the median overall survival (OS) in the respective arms was 23.2 months (95% CI; 19.1-25.2) and 21.2 months (95% CI; 18.0-23.1), with an HR of 0.91 (95% CI, 0.68-1.20).

The primary end point of the trial was rPFS assessed by independent radiologic review and OS was a key secondary outcomes.

The recommended dose for rucaparib in this patient group is 600 mg in two 300-mg tablets taken orally twice daily, totaling 1200 mg. Treatment was continued in the absence of disease progression or unacceptable toxicity.

The prescribing information includes warnings and precautions for myelodysplastic syndrome, acute myeloid leukemia, and embryo-fetal toxicity.

The FDA previously granted rucaparib accelerated approval in the same patient population in May 2020.

References

1. FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer. News release. FDA. December 17, 2025. Accessed December 17, 2025. https://tinyurl.com/57mwhepk
2. FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer. News release. FDA. May 15, 2020. Accessed December 17, 2025. https://tinyurl.com/2szswshf