Posted by Michael Wonder on 04 Jul 2025
Johnson & Johnson submits application to the EMA seeking indication extension of Akeega (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations
3 July 2025 - The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone or prednisolone compared to a current standard of care, abiraterone acetate plus prednisone or prednisolone.
Janssen-Cilag today announced the submission of an extension of indication application to the EMA seeking approval of Akeega (niraparib and abiraterone acetate) with prednisone or prednisolone for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and homologous recombination repair gene alterations.
