Posted by Michael Wonder on 28 Apr 2022
Janssen submits marketing authorisation application to EMA seeking approval of niraparib and abiraterone acetate dual action tablet plus prednisone for the treatment of patients with HRR gene mutated metastatic castration resistant prostate cancer
28 April 2022 - The submission to the EMA is based on results from the Phase 3 MAGNITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who are positive for homologous recombination repair gene alterations.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a marketing authorisation application to the EMA seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual action tablet plus prednisolone, for the treatment of patients with prostate cancer who have progressed to metastatic castration-resistant prostate cancer and are positive for homologous recombination repair gene alterations.
