The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has announced that the European Commission (EC) has approved Akeega (niraparib and abiraterone acetate) in combination with prednisone or prednisolone to treat certain prostate cancer patients.
The marketing authorisation, which marks the first worldwide approval of the niraparib-based combination, specifically applies to adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations in whom chemotherapy is not clinically indicated.
With over 100,000 deaths attributed to the disease in 2020 alone, prostate cancer is the most common cancer in men across Europe.
Patients with mCRPC and homologous recombination repair (HRR) gene alterations, of which BRCA mutations are the most common, are more likely to have aggressive disease, poor outcomes and a shorter survival time, Janssen explained in a statement.
The EC’s decision was based on positive results from the phase 3 MAGNITUDE study, which assessed whether the addition of niraparib to abiraterone acetate and prednisone or prednisolone (AAP) improved outcomes in mCRPC patients with or without certain HRR gene alterations.
The combination was shown to significantly improve radiographic progression-free survival (rPFS) – the primary endpoint of the study – in all HRR-positive patients. This was most pronounced in those with BRCA1/2 gene mutations, the company said, where a 47% risk reduction for rPFS was observed.
An additional median follow-up at 24.8 months in the BRCA subgroup also demonstrated a consistent and clinically meaningful treatment effect favouring niraparib plus AAP, with a median rPFS of 19.5 months compared with 10.9 months for placebo plus AAP.
Additionally, there was a trend towards improved overall survival with the combination, strong improvement in time to symptomatic progression, as well as clinically meaningful improvement in time-to-initiation of cytotoxic chemotherapy.
Martin Vogel, EMEA therapeutic area lead for oncology at Janssen-Cilag GmbH, said: “The MAGNITUDE trial was prospectively designed as a precision medicine study to identify the specific population of patients who would most benefit from niraparib with AAP, and potentially increase the likelihood of treatment success.
“The results, on which this EC approval is based, reinforce the benefit of this niraparib-based combination in effectively addressing BRCA mutations and changing the outlook for patients with mCRPC.”