Janssen reaches Akeega approval milestone

Treatment involves the treatment of adults with metastatic castration-resistant prostate cancer

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the European Commission (EC) has granted marketing authorisation for Akeega.

The therapy is a dual action tablet which combines niraparib and abiraterone acetate (AA) and is provided with prednisone or prednisolone. It specifically concerns the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic). The individuals are also patients for whom chemotherapy is not clinically indicated.

The milestone authorisation – which also marks the first global approval for Akeega – is based on results of the randomised, placebo-controlled, double-blind, phase 3 trial. The MAGNITUDE study assessed whether the inclusion of niraparib to AA and prednisolone improved outcomes in patients with untreated mCRPC.

Meanwhile, the primary endpoint for MAGNITUDE’s research was radiographic progression-free survival (rPFS), as analysed by a blinded central review.

The study ultimately established that niraparib plus AA and prednisolone significantly improved rPFS in all HRR-positive patients. Indeed, this improvement was most pronounced in patients with BRCA1/2 gene mutations, where a statistically significant risk reduction was observed for rPFS.3

Martin Vogel, EMEA therapeutic area lead oncology at Janssen-Cilag GmbH, explained: “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 abiraterone acetate plus prednisolone, and potentially increase the likelihood of treatment success.”

He added: “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.”

Gerhardt Attard, oncologist at University College London, reflected: “Metastatic castration-resistant prostate cancer remains a lethal disease, with high unmet needs in terms of treatment options, particularly for patients with BRCA1/2 gene mutations.”

He concluded: “We’ve seen that in these patients, niraparib combined with abiraterone acetate and prednisolone significantly reduced the risk of disease progression or death compared to AAP. The dual action tablet of niraparib with abiraterone acetate is a promising first line targeted treatment option for men with mCRPC and BRCA1/2 mutations.”

Prostate cancer is the sixth highest cause of cancer-related death worldwide and remains the most common cancer in men across Europe. In spite of treatment advances, mCRPC is still an incurable and deadly disease.