Janssen Subsidiary of Johnson & Johnson Receives CHMP Positive Opinion for Niraparib-Based Akeega as First-Line Treatment for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

Feb 25, 2023 10:19 CST Updated 10:19

Janssen Pharmaceuticals

Pharmaceutical R&D Developer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

On February 24, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Akeega (niraparib + abiraterone acetate) for marketing. It is used in combination with prednisone or prednisolone for the first-line treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are not indicated for chemotherapy and carry BRCA1/2 mutations (germline or somatic).

Niraparib is a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor developed by TESARO (which has been acquired by GSK). In April 2016, Janssen Pharmaceuticals and TESARO reached a collaboration, granting Janssen global development and commercialization rights (excluding Japan) for niraparib in the indication of prostate cancer.

The CHMP's opinion this time is based on the results of the Phase III MAGNITUDE study. This study is a randomized, double-blind, placebo-controlled clinical trial that enrolled a total of 423 patients (including 225 with BRCA mutations) and aims to evaluate the efficacy and safety of niraparib combined with abiraterone acetate and prednisone (AAP) compared with placebo combined with AAP as first-line treatment in patients with mCRPC with or without homologous recombination repair (HRR) gene mutations.

The results of the first interim analysis showed that the radiographic progression-free survival (rPFS) was significantly prolonged in HRR-positive patients (16.5 vs 13.7 months; HR=0.73). In patients carrying BRCA1/2 gene mutations, rPFS was significantly prolonged in the Niraparib plus AAP group (16.6 vs 10.9 months; HR=0.53). At the time of the second interim analysis, the rPFS of patients carrying BRCA1/2 gene mutations had been prolonged to 19.5 months.

Prostate cancer is the most common cancer in European men. Up to one-third of patients with prostate cancer will progress (often driven by androgens) to metastatic disease, with a 5-year survival rate of only 30%. Approximately 10-15% of mCRPC patients carry BRCA1/2 gene mutations.

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