Rucaparib Receives Accelerated Approval for Metastatic Castration-Resistant Prostate Cancer
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 accessdata.fda.gov.