Janssen Receives Positive Opinion for AKEEGA Plus Prednisone or Prednisolone

Janssen announced on Feb. 24, 2023 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for AKEEGA (niraparib and AA) in the form of DAT, given with prednisone or prednisolone, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

If approved, the treatment will be the first dual action tablet (DAT) available in the European Union for first-line treatment of adult patients with mCRPC with BRCA1/2 mutations. Niraparib is a highly selective poly adenosine diphosphate-ribose polymerase (PARP) inhibitor. Alongside AA, a cytochrome P450 17α-hydroxylase (CYP17) inhibitor, the combination DAT regimen targets two oncogenic drivers in patients with mCRPC.

“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, in a company press release. “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.”