Janssen Submits NDA for Niraparib-Abiraterone Tablet for Hormone-Sensitive Prostate Cancer

Aug 22, 2025 20:20 CST Updated 20:20

Johnson & Johnson

Medical Device R&D and Manufacturer

On August 22, the CDE website showed that Johnson & JohnsonNiraparib Abiraterone TabletsNew indication marketing application accepted. Based on publicly available data and clinical progress, the indication for this submission is inferred to beHormone-dependent Prostate Cancer。

Screenshot source: CDE official website

Niraparib Abiraterone is a compound preparation launched by Johnson & Johnson.Approved for marketing in the European Union and the United States in 2023, respectively, for use in combination with prednisone or prednisolone as a first-line treatment for adult patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer (mCRPC).

At the 2025 ASCO Conference, Johnson & Johnson delivered an oral presentation.For the first timePublishedClinical outcomes of the AMPLITUDE study. This is aPhase III, Randomized, Placebo-Controlled, Double-Blind Study.

The results showed that:Primary Endpoint Achieved, the overall experimental groupMedian rPFS has not been reached, butSignificantly longer than the control group(29.5 months). Similar results were shown in the pre-specified BRCA1/2 subgroup, with a median in the experimental group.rPFS not reached, median in the control grouprPFS was 26 months.

In terms of secondary endpoints, the trial group'sTime to Symptom Progression（TSP）Significant Improvement，The risk of symptom progression was reduced by 50%, whileThe risk of symptom progression in the BRCA1/2 subgroup was reduced by 56%. Additionally, in the first interim analysis, the experimental group demonstratedTrend of Improved Overall OS。

Statement：This ArticleAimed at promoting communication and exchange in pharmaceuticals and medicine, for healthcare professionals only, MedSci MedicalDo not recommend any drugs and/or indications.In the textThe drug information provided is for reference only and should not be considered as a substitute for professional medical advice or treatment recommendations in any way. If you wish to obtain specific disease diagnosis and treatment information, please follow the advice or guidance of your doctor at the hospital.

Previous ·Recommendation

Immunotherapy ≠ Panacea: These 4 Types of Lung Cancer Patients Should Not Use PD-1

Comprehensive Summary of Cancer Drug Resistance! President Ge of Zhejiang Provincial People's Hospital, First Author Publishes Nature Review

What to Do After PD-1 Inhibitor Resistance? Six Latest Solutions to Overcome Challenges

A Summary Table of Neoadjuvant Treatment Options for Triple-Negative Breast Cancer

Star mark?"MedSci Oncology New Frontier"

?Timely ReceptionEach newly published tweet!