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The FDA has granted accelerated approval to rucaparib (Rubraca®, Clovis Oncology, Inc.) for patients with deleterious germline and/or somatic BRCA-mutated metastatic castration-resistant prostate cancer (CRPC) who have previously received one line of taxane-based chemotherapy and one or more lines of androgen receptor-directed therapy.
The approval was based on TRITON2 (NCT02952534), a phase 2 clinical trial which enrolled 115 patients with BRCA-mutated metastatic CRPC. Patients received 600 mg of rucaparib orally twice daily until disease progression or drug discontinuation. The study's primary end point was objective response rate, with a secondary end point of duration of response.
In 62 patients with measurable disease, rucaparib produced an objective response rate of 43.9%. Durations of response ranged from 1.7 to more than 24 months; the median duration was not yet evaluable. Responses lasting 6 months or longer were seen in 56% of patients who experienced a response.
Adverse events occurring in at least 20% of patients included fatigue, nausea, anemia, increased aspartate aminotransferase/alanine aminotransferase (AST/ALT), decreased appetite, rash, constipation, thrombocytopenia, vomiting, and diarrhea. Anemia/decreased hemoglobin was the most common treatment-emergent adverse event of grade 3 or higher, occurring in 16.2% of patients.
"Consistent with prior reports, rucaparib demonstrates promising efficacy in patients with metastatic CRPC and a germline or somatic BRCA or other DNA damage response (DDR) gene alteration," concluded the investigators of TRITON2, led by first author Wassim Abida, MD, PhD, a medical oncologist at Memorial Sloan Kettering Cancer Center, in their updated analysis of the trial presented last October at the European Society for Medical Oncology (ESMO) 2019 Congress. "The safety profile of rucaparib is consistent with prior reports in ovarian and prostate cancer."
The recommended dose of rucaparib for patients with BRCA-mutated metastatic CRPC is 600 mg administered orally twice daily, with or without food. Patients treated with rucaparib should have previously received a bilateral orchiectomy or should be concurrently receiving a gonadotropin-releasing hormone (GnRH) analog.
For More Information
Abida W, Campbell D, Patnaik A, et al (2019). Preliminary results from the TRITON2 study of rucaparib in patients (pts) with DNA damage repair (DDR)-deficient metastatic castration-resistant prostate cancer (mCRPC): updated analyses. Ann Oncol (ESMO Congress Abstracts), 30(suppl_5):v327-v328. Abstract 846PD. DOI:10.1093/annonc/mdz248.003
US Food & Drug Administration (2020). FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer. Available at: https://www.fda.gov/drugs/fda-grants-accelerated-approval-rucaparib-brca-mutated-metastatic-castration-resistant-prostateRubraca® (rucaparib) prescribing information (2019). Clovis Oncology, Inc. Available at: https://clovisoncology.com/pdfs/RubracaUSPI.pdf
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