First approval worldwide for Akeega with EC authorization for metastatic castration resistant prostate cancer with BRCA1/2 mutations.- Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson announced 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.
Prostate cancer is the most common cancer in men in Europe, and the sixth-highest cause of cancer-related death worldwide. Despite treatment advances, mCRPC remains an incurable, deadly disease. BRCA1/2 gene mutations have been identified in approximately 10-15 percent of mCRPC patients and are more likely to cause aggressive disease, poor outcomes, and a shorter survival time.
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