Horsham: J ohnson & Johnson has announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for AKEEGA (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).

Patients with BRCA mutations often have more aggressive forms of prostate cancer leading to poor prognosis, representing a significant unmet need not addressed by previously available therapies.

“There remains an urgent need for novel therapies for patients with BRCA2-mutated mCSPC, who face significantly faster disease progression and often shorter survival compared to those without the mutation,” said Bradley McGregor, M.D., Director of Clinical Research

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