The FDA has granted full approval to rucaparib (Rubraca) for adults with BRCA-mutated metastatic castration-resistant prostate cancer.
The decision is based on a confirmatory analysis of a randomized trial of 405 patients who had progressed on prior androgen receptor pathway inhibitors, according to a Dec. 17 news release from the agency. Among the 302 patients with BRCA mutations, rucaparib showed a statistically significant improvement in radiographic progression-free survival compared to standard treatments, with a median of 11.2 months versus 6.4 months.
Rucaparib received accelerated approval in 2020 for a similar indication. The agency said patients should be selected using an FDA-approved companion diagnostic.
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