The combination therapy of niraparib and abiraterone acetate (AA) could become the first dual action tablet (DAT) available in the European Union for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations.
Janssen’s Akeega has been recommended for marketing authorisation when given with prednisone (P) or prednisolone by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The positive opinion is based on results from the Phase III MAGNITUDE study where the addition of niraparib to AA plus P significantly improved radiographic progression-free survival (rPFS) compared to standard of care in untreated mCRPC patients with BRCA1/2 mutations.
Niraparib is a highly selective poly adenosine diphosphate-ribose polymerase (PARP) inhibitor. Together with AA, a cytochrome P450 17α-hydroxylase (CYP17) inhibitor, the combination DAT regimen targets two oncogenic drivers in patients with mCRPC, namely androgen receptor axis (AR-axis) and BRCA1/2 gene mutations.
A lethal disease
Prostate cancer is the most common cancer in men in Europe. Despite treatment advances, for those whose cancer has progressed to mCRPC, the impact can be devastating, with an average overall survival ranging from 13-36 months.
Patients with mCRPC and BRCA gene mutations are more likely to have aggressive disease, poor outcomes and a shorter survival time.
“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,” said Elena Castro, Consultant Oncologist, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre, Madrid, Spain. “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.
“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.”