Johnson & Johnson (J&J, NYSE: JNJ), a leading US pharmaceutical company, has announced that China’s National Medical Products Administration (NMPA) has granted indication approval for Akeega (niraparib and abiraterone acetate), to be taken with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations, germline and/or somatic. This marks Akeega as the first-and-only dual action tablet (DAT) of its kind in China.
The dual action tablet combines niraparib, a highly selective poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, with abiraterone acetate (AA) and a corticosteroid, targeting two key oncogenic drivers in patients with mCRPC: alterations in the androgen receptor axis and in BRCA1/2. Clinical studies have demonstrated that the combination of niraparib with abiraterone acetate and prednisone (AAP) significantly improved radiographic progression-free survival (rPFS). There was also a trend towards improved overall survival (OS) with the AAP regimen, a strong improvement in time to symptomatic progression (TSP), and a clinically meaningful improvement in time-to-initiation of cytotoxic chemotherapy (TCC). This innovative treatment approach offers a promising first-line targeted therapy option for men with mCRPC and BRCA1/2 mutations.
Akeega’s marketing approval in China follows its approval in the US in August of last year, highlighting the drug’s potential to become a standard of care for patients with mCRPC and BRCA1/2 mutations globally.- Flcube.com
