Janssen's Niraparib-Abiraterone Tablet Approved in China for BRCA-Mutated mCRPC

Oct 23, 2024 16:01 CST Updated 16:01

Johnson & Johnson

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On October 21, Johnson & Johnson announced that its newly developed Niraparib Abiraterone Tablets had officially received approval from China's National Medical Products Administration (NMPA) for market launch. The drug will be used in combination with prednisone or prednisolone, specifically for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying germline and/or somatic BRCA gene mutations. According to publicly available data, this new medication combines the PARP inhibitor niraparib with the androgen biosynthesis inhibitor abiraterone, forming a compound therapy.

Prostate cancer is one of the most common malignant tumors in men. Although the majority of men diagnosed with localized prostate cancer can be treated with surgery or radiation therapy, the growth of prostate cancer cells relies on androgens. As a result, patients may still develop metastatic castration-resistant prostate cancer (mCRPC) after undergoing androgen deprivation therapy (ADT). Statistics show that approximately 10% to 50% of patients will progress to mCRPC within three years of diagnosis, with about 10% to 15% of these patients carrying BRCA gene mutations.

Niraparib, an oral PARP1/2 inhibitor taken once daily, has been approved in the United States, the European Union, and China for the treatment of advanced ovarian cancer and is currently undergoing clinical trials in the field of prostate cancer treatment. In 2016, Johnson & Johnson partnered with TESARO (now acquired by GlaxoSmithKline) to study the drug's efficacy in treating prostate cancer. That same year, Zai Lab also signed a strategic cooperation agreement with TESARO, securing exclusive rights for the development and commercialization of niraparib in the Chinese market.

Abiraterone is an androgen synthesis inhibitor that can suppress the production of the CYP17 enzyme complex, thereby reducing the production of androgens in the body.

Johnson & Johnson's press release noted that the combination of niraparib and abiraterone, along with prednisone or prednisolone, can target two major carcinogenic factors in mCRPC patients—the androgen receptor axis and BRCA1/2 mutations.

Previously, the combination of niraparib and abiraterone acetate tablets has shown positive data in MAGNITUDE, a Phase 3, randomized, double-blind, placebo-controlled multicenter clinical study. This study evaluated the safety and efficacy of the combination therapy with prednisone as a first-line treatment for patients with mCRPC, with or without homologous recombination repair (HRR)-related gene mutations. The primary results demonstrated that radiographic progression-free survival (rPFS) risk was significantly reduced by 47% in BRCA-positive patients receiving the combination of niraparib, abiraterone acetate, and prednisone. Additionally, for secondary endpoints such as time to symptomatic progression (TSP), time to initiation of cytotoxic chemotherapy (TCC), and overall survival (OS), the combination therapy group also showed an improving trend. Meanwhile, the safety profile of this combination therapy was consistent with the known safety profiles of each individual approved medication.

The editor has compiled a list of currently approved targeted drugs and immunotherapies for prostate cancer. If you wish to learn more about prostate cancer-related knowledge, you can contact the assistant at the end of the article.

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