Akeega (Niraparib + Abiraterone Acetate) Receives First Global Approval for First-Line Treatment of BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

Apr 22, 2023 08:01 CST Updated 08:01

Janssen Pharmaceuticals

Pharmaceutical R&D Developer

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

European Commission

The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.

On April 21, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, announced that the European Commission (EC) has approved Akeega (niraparib + abiraterone acetate) for marketing. It will be used in combination with prednisone or prednisolone as a first-line treatment for adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are not indicated for chemotherapy and carry BRCA1/2 mutations (germline or somatic). This marks the first global approval of Akeega.

The combination of Niraparib (a highly selective PARP inhibitor) and Abiraterone Acetate (a CYP17 inhibitor), along with Prednisone, can target two oncogenic drivers in mCRPC patients—the androgen receptor axis and HRR gene alterations. BRCA mutation is one type of homologous recombination repair (HRR) gene alteration. In April 2016, Johnson & Johnson partnered with TESARO (acquired by GSK) to obtain global (excluding Japan) development and commercialization rights for Niraparib in prostate cancer indications.

This approval is based on the results of the Phase III MAGNITUDE study. The study was a randomized, double-blind, placebo-controlled clinical trial that enrolled 423 patients (including 225 patients with BRCA mutations) and aimed to evaluate the efficacy and safety of niraparib in combination with abiraterone acetate and prednisone (AAP) compared to placebo plus AAP as a first-line treatment for mCRPC patients with or without homologous recombination repair (HRR) gene mutations.

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 with BRCA1/2 mutations, rPFS was significantly prolonged in the niraparib plus AAP group (16.6 vs 10.9 months; HR=0.53). At the second interim analysis, the rPFS of patients with BRCA1/2 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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