Johnson & Johnson：Akeega®Niraparib and Abiraterone Acetate Tabletsapproved for marketing in China.
On June 22, Johnson & Johnson announced that its innovative therapeutic drug Zebeka® (niraparib and abiraterone acetate tablets) has received official approval from the National Medical Products Administration (NMPA) for use in combination with prednisone or prednisolone for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) carrying germline and/or somatic BRCA2 gene mutations.
In October 2024, the product had already been approved in China for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying germline and/or somatic BRCA gene mutations. As the first and currently only precision combination therapy in China specifically targeting BRCA-mutant prostate cancer, this new indication expansion fills a critical unmet clinical need for this patient population.
The NMPA approval is based on positive data from the AMPLITUDE study. AMPLITUDE is a global, multicenter, randomized, placebo-controlled, double-blind Phase III study that enrolled 696 patients with HRR gene-mutated metastatic castration-sensitive prostate cancer. Patients were randomized 1:1 to receive niraparib + abiraterone + prednisone (n=348) or placebo + abiraterone + prednisone (n=348) in combination with ADT. The results demonstrated that compared with the current standard of care, the niraparib, abiraterone, and prednisone combination plus androgen deprivation therapy (ADT) significantly prolonged radiographic progression-free survival (rPFS), reducing the risk of disease progression or death by 54% (HR=0.46; 95% CI: 0.32–0.66). In addition, the therapy significantly delayed the time to symptomatic progression (TSP), reducing the risk of symptomatic progression by 59% (HR=0.41; 95% CI: 0.29–0.65). In terms of safety, the safety profile of niraparib and abiraterone in mHSPC patients was consistent with previous observations in mCRPC patients, with no new safety signals identified.
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