(News Bulletin 247) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced on Friday that the European Commission (EC) has granted marketing authorization for Akeega® (niraparib and abiraterone acetate [AA]), as a dual action tablet (DAT), administered with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/ 2 in whom chemotherapy is not clinically indicated.
Prostate cancer is the most common cancer in men in Europe and the sixth leading cause of cancer-related death worldwide, says J&J.
‘Niraparib dual-action tablet with abiraterone acetate is a promising first-line targeted treatment option for men with mCRPC and BRCA1/2 mutations,’ says Professor Gerhardt Attard, oncologist at University College London (UCL ).
The CE clearance also marks the first worldwide approval of Akeega®. It is based on the results of a randomized, double-blind, placebo-controlled, phase 3 study.
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