Janssen's First-in-China Combination Therapy Submits New Indication Application in China for Hormone-Sensitive Prostate Cancer

On August 22, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) showed,Niraparib submitted by Johnson & JohnsonAbiraterone TabletsNew indication marketing application has been officially accepted.Combined with Johnson & Johnson's recent global registration and submission trends and related clinical evidence, it is speculated that the indication for this submission in China is likely related toConsistent with its extension application submitted in Europe in July 2025：Combined with prednisone orPrednisoloneFor the treatment of patients with hormone-dependent prostate cancer.

Source: CDE official website

Source of the image:Johnson & JohnsonOfficial Website

The application is mainly supported by the clinical data from the Phase III AMPLITUDE study.The study is a Phase III, randomized, placebo-controlled, double-blind study,Its PARP inhibitorniraparibUnitedAbiraterone AcetateAnd prednisone (AAP) in carriers of homologous recombination repair (HRR) gene mutations (includingBRCA) Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Efficacy in patients.The study included 696 mCSPC patients carrying HRR gene mutations. The primary endpoint of the study wasProgression-Free Survival in Imaging。

The analysis shows,The trial met the primary endpoint of rPFS.。In BRCA-mutated patients (n=191), niraparib combination therapy demonstrated significant benefit, with the median rPFS not yet reached, compared to 26 months in the control group, reducing the risk of radiographic disease progression or death.Reduced by 48%(HR=0.52; 95% CI: 0.37-0.72, p<0.0001). In all patients with HRR mutations, the median rPFS was not reached in the niraparib combination therapy group, while the median rPFS in the control group was 29.5 months, indicating a reduction in the risk of disease progression or death.Reduced by 37%（HR=0.63；95% CI：0.49-0.80，p=0.0001）。

In terms of safety, grade 3/4 adverse events (AEs) were more common in the niraparib combination therapy group (75% vs. 59%), with anemia and hypertension being the most frequent adverse reactions; however, the discontinuation rate due to adverse events remained low (14.7% vs. 10.3%). As of now,Niraparib in combination withAbiraterone AcetateThe safety profile of prednisone was consistent with previous studies.

Niraparib Abiraterone, a combination drug launched by Johnson & Johnson, was approved in the EU and the United States in 2023. It is used in combination with prednisone or prednisolone for the first-line treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying BRCA1/2 mutations.In October 2024, the drug was approved for the first time in China, becoming the first and only dual-action combination formulation approved in China.

The acceptance of this new indication application marks the further expansion of the indications for Niraparib Abiraterone in the field of prostate cancer treatment, providing more treatment options for patients in China.

       Title: First in China! Johnson & Johnson's Key Product Submits New Indication Application