On May 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib (Rubraca) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy and a taxane-based chemotherapy.
TRITON2
Efficacy was investigated in TRITON2, an ongoing, multicenter, single-arm clinical trial that studied 115 patients with BRCA-mutated (germline and/or somatic) metastatic castration-resistant prostate cancer who had been treated with androgen receptor–directed therapy and taxane-based chemotherapy. Patients received rucaparib at 600 mg orally twice daily and concomitant gonadotropin-releasing hormone analog or had prior bilateral orchiectomy.
Objective response rate and duration of response were assessed in 62 patients with measurable disease. The confirmed objective response rate was 44% (95% confidence interval [CI] = 31%–57%). Median duration of response was not evaluable (95% CI = 6.4–not evaluable). The range for the duration of response was 1.7 to 24+ months. Of the 27 patients with confirmed objective responses, 15 (56%) had a duration of response ≥ 6 months.
The most common adverse reactions (≥ 20%) among all 115 patients with BRCA-mutated metastatic castration-resistant prostate cancer were fatigue, nausea, anemia, increased ALT/AST, decreased appetite, rash, constipation, thrombocytopenia, vomiting, and diarrhea.
The recommended rucaparib dose is 600 mg orally twice daily with or without food. Patients receiving rucaparib for metastatic castration-resistant prostate cancer should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.
