Rucaparib receives FDA approval for BRCA-mutated metastatic castration-resistant prostate cancer

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FDA has granted an 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.

Rubraca is sponsored by Clovis Oncology Inc.

Efficacy was investigated in TRITON2 (NCT02952534), an ongoing, multi-center, single arm clinical trial in 115 patients with BRCA-mutated (germline and/or somatic) mCRPC who were treated with androgen receptor-directed therapy and taxane-based chemotherapy. Patients received rucaparib 600 mg orally twice daily and concomitant GnRH analog or had prior bilateral orchiectomy.

Objective response rate and duration of response were assessed in 62 patients with measurable disease. The confirmed ORR was 44% (95% CI: 31, 57). Median DOR was not evaluable (NE; 95% CI: 6.4, NE). The range for the DOR was 1.7-24+ months. Fifteen of the 27 (56%) patients with confirmed objective responses had a DOR of ≥6 months.

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Credit: Jonah Elkowitz/ShutterstockThat President Biden was diagnosed with prostate cancer is certainly unfortunate news, but it should come as no surprise. One in eight men in the U.S. will be told they have prostate cancer at some point in their lifetime: more than 300,000 new diagnoses occur annually, and the absolute numbers are rising. 

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