Janssen Submits Marketing Authorization Application for Treatment of Metastatic Castration-Resistant Prostate Cancer

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Janssen has submitted a marketing authorization application to EMA for the approval of a treatment for patients with HRR gene-mutated metastatic castration-resistant prostate cancer.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on April 28, 2022 the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of niraparib and abiraterone acetate dual-action tablet plus prednisone for the treatment of patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

Upon approval, niraparib and abiraterone acetate plus prednisone will be the first dual-action tablet in the European Union specifically targeting HRR gene alterations in mCRPC, according to the company. The combination is intended to be more convenient for patients and thus improve treatment compliance.

Prostate cancer is one of the most common cancers in Europe, with approximately 473,000 patients diagnosed in 2020, according to the company. Up to approximately 30% of patients with mCRPC have HRR gene alterations, which are associated with a worse prognosis compared to those without HRR gene alterations.


“People with prostate cancer harboring BRCA alterations face a more aggressive form of disease with worse outcomes and faster progression, sadly leading to a shorter life expectancy,” commented Professor Gerhardt Attard, primary study investigator and clinician scientist and team leader at University College London Cancer Institute, in a press release. “This submission is an important step towards improving the outcomes for people with metastatic prostate cancer harboring BRCA alterations using a targeted therapy that significantly delays the time to their cancer progressing.”

Source: Janssen