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FDA has granted accelerated approval to Rubraca for BRCA-mutated metastatic castration-resistant prostate cancer


The FDA ( Food and Drug Administration ) has granted accelerated approval to Rubraca ( Rucaparib ) 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, an ongoing, multi-center, 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 GnRH analog 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% 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 or more.

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

The recommended Rucaparib dose is 600 mg orally twice daily with or without food.
Patients receiving Rucaparib for mCRPC should also receive a gonadotropin-releasing hormone ( GnRH ) analog concurrently or should have had bilateral orchiectomy.

The indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. ( Xagena )

Source: FDA, 2020

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