Posted by Michael Wonder on 24 Apr 2023
Janssen marks first approval worldwide for Akeega (niraparib and abiraterone acetate dual action tablet) with EC authorisation for the treatment of patients with metastatic castration resistant prostate cancer with BRCA1/2 mutations
21 April 2023 - Approval for Akeega is based on results from the Phase 3 MAGNITUDE study, a prospectively designed precision medicine study that includes the largest cohort to date of BRCA1/2 positive patients with untreated metastatic castration-resistant prostate cancer.
Janssen announced today that the European Commission has granted marketing authorisation for Akeega (niraparib and abiraterone acetate), in the form of a dual action tablet, given with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
