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FDA Grants Accelerated Approval to Rucaparib for BRCA-mutated Metastatic Castration-Resistant Prostate Cancer

Evidence for efficacy is based on the results from the TRITON2 study
19 May 2020
Anticancer agents & Biologic therapy;  Genitourinary cancers;  Personalised medicine

On 15 May 2020, the US Food and Drug Administration (FDA) granted accelerated approval to rucaparib (RUBRACA, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

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

Objective response rate (ORR) and duration of response (DoR) were assessed in 62 patients with measurable disease. The confirmed ORR was 44% (95% confidence interval [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. 

The most common adverse reactions (≥20%) among all 115 patients with BRCA-mutated mCRPC were fatigue, nausea, anaemia, increased ALT/AST, decreased appetite, rash, constipation, thrombocytopenia, vomiting, and diarrhoea.

The recommended rucaparib dose is 600 mg orally twice daily with or without food.

Patients receiving rucaparib for mCRPC should also receive a GnRH analogue concurrently or should have had bilateral orchiectomy.

Full prescribing information for RUBRACA is available here.

This indication is approved under accelerated approval based on ORR and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Rucaparib previously was granted Breakthrough Therapy designation for this indication. This application was granted priority review.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.

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