US FDA Priority Review for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) in BRCA-mutated metastatic CSPC
The U.S. Food and Drug Administration (FDA) granted Priority Review to Johnson & Johnson for its supplemental New Drug Application (sNDA) for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA-mutated metastatic castration-sensitive prostate cancer (mCSPC). Patients with BRCA mutations have a poor prognosis, representing a significant unmet medical need not addressed by currently available therapies.
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