Posted by Michael Wonder on 24 Feb 2023
Janssen receives positive CHMP opinion for Akeega (niraparib and abiraterone acetate dual action tablet) plus prednisone or prednisolone for the treatment of adult patients with BRCA1/2 gene mutated metastatic castration resistant prostate cancer
24 February 2023 - The positive CHMP opinion is based on results from the Phase 3 MAGNITUDE study where the addition of niraparib to abiraterone acetate plus prednisone significantly improved radiographic progression-free survival compared to standard of care in untreated mCRPC patients with BRCA1/2 mutations.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the CHMP of the EMA has recommended 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 adult patients with metastatic castration-resistant prostate cancer and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
