The Janssen Pharmaceutical Companies of Johnson & Johnson has received marketing approval from the European Commission (EC) for Erleada (apalutamide) intended to treat non-metastatic castration-resistant prostate cancer (nmCRPC).

The product is a next generation oral androgen receptor inhibitor approved to treat adult patients with nmCRPC who are at high risk of developing metastatic disease. It has the capacity to block the androgen signalling pathway in prostate cancer cells. It can restrict the growth of cancer cells in three ways, including preventing the binding of androgen to the AR, stopping the AR from entering the cancer cells and the AR from binding to the DNA of the cancer cell.

The approval was based on data from the phase three Spartan study, which assessed the efficacy and safety of apalutamide plus androgen deprivation therapy (ADT) against placebo plus ADT in patients with nmCRPC who had a rapidly rising prostate specific antigen level even though providing continuous ADT.