Prostate Cancer Coverage from Every Angle

Rucaparib Receives Accelerated Approval for Metastatic Castration-Resistant Prostate Cancer

By: Jocelyn Solis-Moreira, MS
Posted: Tuesday, May 19, 2020

On May 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the PARP inhibitor rucaparib (Rubraca) for patients with deleterious BRCA mutations (germline and/or somatic)-associated metastatic castration-resistant prostate cancer. Eligibility for rucaparib also includes a history of androgen receptor–directed therapy and a taxane-based chemotherapy.

The recommended dosage of rucaparib 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 have had a bilateral orchiectomy.

The accelerated approval is based on current data from the ongoing, multicenter, single-arm TRITON2 trial. A total of 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 enrolled in the study. All patients were given a 600-mg oral dose of rucaparib twice a day along with a gonadotropin-releasing hormone analog unless they had a bilateral orchiectomy.

Of 62 evaluated patients, the objective response rate was 44% (95% confidence interval = 31%–57%), and the duration of response ranged from 1.7 months to 24 or more months. In addition, 56% of patients with confirmed objective responses had a duration of response of 6 or more months.

Common adverse reactions in 20% or more of patients given rucaparib included fatigue, nausea, anemia, increased alanine aminotransferase/aspartate transaminase levels, decreased appetite, rash, constipation, thrombocytopenia, vomiting, and diarrhea.

For more prescribing information, visit

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.