Janssen's Precision Combination Therapy Zebetek® (Niraparib Abiraterone Acetate Tablets) Granted New Indication in China for BRCA2-Mutated mHSPC
Johnson & Johnson
Medical Device R&D and Manufacturer
On June 22, Johnson & Johnson announced that its innovative therapeutic drug, Zepzelca®(Niraparib Abiterone Tablets)Officially approved by the National Medical Products Administration (NMPA),Combination with prednisone or prednisolone for adult patients with metastatic hormone-sensitive prostate cancer harboring germline and/or somatic BRCA2 gene mutations（mHSPC）。
Source: Johnson & Johnson Official WeChat Account
In October 2024, the product was previously approved in China for the treatment of adult patients with metastatic castration-resistant prostate cancer harboring germline and/or somatic BRCA gene mutations.（mCRPC）AsThe First and Currently Only Precision Combination Therapy for BRCA-Mutated Prostate Cancer in China, this expansion to a new indication addresses the urgent unmet clinical treatment needs of this patient population.
ThisThe approval by the State Drug Administration is based on positive data from the AMPLITUDE study.AMPLITUDE is aGlobal, Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase III Study,Inclusion696 casesPatients with metastatic castration-sensitive prostate cancer harboring HRR gene mutations were randomized in a 1:1 ratio to receive niraparib plus abiraterone and prednisone（n=348）or placebo + abiraterone + prednisone（n=348）Combined ADT therapy.
The results showed that, compared with the current standard of care,Niraparib AbiteroneCombined Prednisone and Androgen Deprivation Therapy（ADT）Significantly Prolongs Imaging-Based Progression-Free Survival（rPFS），54% Reduction in the Risk of Disease Progression or Death（HR=0.46；95% CI：0.32–0.66）. Meanwhile, this therapy also significantly delayed the time to symptom progression in patients.（TSP）, reducing the risk of symptom progression by 59%（HR=0.41；95% CI：0.29–0.65）。
In terms of safety,Niraparib AbiteroneThe safety profile in patients with mHSPC was consistent with that previously observed in patients with mCRPC, and no new safety signals were identified.