medwireNews: The EMA has recommended granting a marketing authorization for Akeega (Janssen-Cilag International NV, Beerse, Belgium), a fixed-dose combination of niraparib and abiraterone acetate, for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
The decision by the Committee for Medicinal Products for Human Use states that the dual-action therapy is indicated for adult patients with mCRPC carrying germline and/or somatic BRCA1 or BRCA2 mutations who are not able to receive chemotherapy.
Akeega will be available in tablet form in fixed-dose combinations of niraparib 50 mg plus abiraterone 500 mg or niraparib 100 mg plus abiraterone 1000 mg, and should be given alongside prednisone or prednisolone.
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