The Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing approval from the European Commission (EC) for Erleada (apalutamide) to treat non-metastatic castration-resistant prostate cancer (nmCRPC).
Erleada is a next generation oral androgen receptor inhibitor approved to treat adult patients with nmCRPC who are at high risk of developing metastatic disease.
Apalutamide holds capacity to block the androgen signaling pathway in prostate cancer cell.
Apalutamide 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 3 Spartan study, which evaluated 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 (PSA) level even though providing continuous ADT.
According to the company, the study’s results demonstrate that apalutamide plus ADT significantly reduced the risk of developing distant metastasis or death by 72% compared against placebo in combination with ADT and the median MFS was improved by more than two years in patients with nmCRPC whose PSA is rapidly increasing.
Non-metastatic castration-resistant prostate cancer (CRPC) is a disease stage, under which the cancer will not respond o medical or surgical treatments that reduce testosterone.
Janssen oncology solid tumor therapy area lead for Europe, Middle East and Africa lead Dr Ivo Winiger-Candolfi said: “Today’s approval of apalutamide is a significant milestone and we are pleased that we can now offer patients with high-risk non-metastatic castration-resistant prostate cancer a new treatment option.
“Bringing medicines to patients at earlier stages of disease is vital, and the approval of apalutamide could mark a step change in how we treat prostate cancer in the future. Crucially, treating patients at this stage could delay the cancer from spreading, a key part of our commitment to patients living with this disease and to their families.”