Janssen Marks First Approval Worldwide for AKEEGA®

Janssen Marks First Approval Worldwide for AKEEGA® with EC Authorisation for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer

Janssen Marks First Approval Worldwide for AKEEGA®

Approval for AKEEGA® is based on results from the Phase 3 MAGNITUDE study, aprospectively designed precision medicine study that includes the largest cohort to date of BRCA1/2-positive patients with untreated metastatic castration-resistant prostate cancer (mCRPC).1,2Niraparib in combination with abiraterone acetate (AA), plus prednisone or prednisolone,significantly improved radiographic progression-free survival (rPFS) compared to standard of care in untreated mCRPC patients with BRCA1/2 mutations.3

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form of a dual action tablet (DAT), given with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. 2

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