Janssen Marks First Approval Worldwide for AKEEGA ® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations

BEERSE, Belgium, 21 April 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today 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.2Prostate cancer is the most common cancer in men in Europe, and the sixth-highest cause of cancer-related death worldwide.1,2 Despite treatment advances, mCRPC remains an incurable, deadly disease.3,4 BRCA1/2 gene mutations have been identified in approximately 10-15 percent of mCRPC patients5,6 and are more likely to cause aggressive disease, poor outcomes, and a shorter survival time.7,8,9,10“Metastatic castration-resistant prostate cancer remains a lethal disease, with high unmet needs in terms of treatment options, particularly for patients with BRCA1/2 gene mutations,” said Professor Gerhardt Attard, Oncologist, University College London (UCL), London, UK*. “We’ve seen that in these patients, niraparib combined with abiraterone acetate and predniso(lo)ne (AAP) significantly reduced the risk of disease progression or death compared to AAP. The dual action tablet of niraparib with abiraterone acetate is a promising first line targeted treatment option for men with mCR...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news