FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

FDA

17 December 2025 - Today, the FDA approved rucaparib (Rubraca, pharmaand) for adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy. 

Patients should be selected for therapy using an FDA approved companion diagnostic.

Rucaparib was granted accelerated approval in 2020 for a similar indication.

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US , Registration