Positive CHMP opinion for Janssen’s AKEEGA

If approved company’s prostate cancer therapy will be the first dual-action tablet available in EU

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for AKEEGA.

The therapy is comprised of niraparib in combination with abiraterone acetate (AA) when given with prednisone (P) or prednisolone. It is delivered in the form of a dual-cation tablet and is for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic). Patients are also individuals for whom chemotherapy is not clinically indicated.

Niraparib is a selective poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, while AA is a cytochrome inhibitor. When combined, they target two mutations responsible for prostate cancer in patients with mCRPC.

The opinion emerged following results from the double-blind, randomised, placebo-controlled phase 3 MAGNITUDE study. The research assessed whether the addition of niraparib to AAP improved outcomes in those with first-line mCRPC, with or without alterations in homologous recombination repair associated genes.

Elena Castro, consultant oncologist at Instituto de Investigación Sanitaria Hospital, reflected “mCRPC remains a lethal disease, with high unmet needs in terms of treatment options, particularly for patients with BRCA1/2 gene mutations. We’ve seen that in these patients, niraparib combined with abiraterone acetate and prednisone significantly reduces the risk of disease progression or death compared to AAP.”

She added: “This niraparib-based regimen is a welcomed targeted treatment option and, if approved, has the potential to impact the standard of care for men with mCRPC BRCA who are treated with first-line therapy.”

Martin Vogel, EMEA therapeutic area lead oncology at Janssen-Cilag GmbH, concluded: “The positive CHMP opinion reinforces the benefit of this niraparib combination and marks an important milestone in addressing BRCA1/2 mutations as we continue to drive progress towards changing the outlook for patients with mCRPC.”

Prostate cancer is the most common cancer in men across Europe. In spite of treatment advances, for those whose cancer has progressed to mCRPC, the consequences can be very serious, with average overall survival ranging from 13 to 36 months.