European Commission Approves Janssen's Erleada for Patients at High Risk of Developing Metastatic Prostate Cancer

  • Erleada is also approved in the US for the treatment of non-metastatic castration-resistant prostate cancer


The Janssen Pharmaceutical Companies of Johnson & Johnson announced on 1/16/19 that the European Commission (EC) has granted marketing authorisation for ERLEADA® (apalutamide), a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

The EC approval is based on data from the pivotal Phase 3 SPARTAN study, which was published in The New England Journal of Medicine. The study assessed the efficacy and safety of apalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in patients with nmCRPC who had a rapidly rising prostate specific antigen (PSA) level despite receiving continuous ADT. Findings from the study showed that apalutamide plus ADT, significantly reduced the risk of developing distant metastasis or death (metastasis free survival [MFS]) by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P < 0.001). The median MFS was improved by over two years (40.5 months vs. 16.2 months) in patients with nmCRPC whose PSA is rapidly rising

“One of the key goals in prostate cancer treatment is to delay the disease from spreading. Once the cancer spreads, it can become less responsive to treatment, impacting patients’ quality of life and ultimately worsening their prognosis. Median survival for these patients is approximately three years,” said Dr Simon Chowdhury, Consultant Medical Oncologist, Guy's and St Thomas' Hospitals, London. “It is crucial that we delay the development of metastases for as long as possible. Therefore, the approval of apalutamide, a treatment which can significantly increase time without metastases, is a major step-forward for patients with prostate cancer.”

Apalutamide is a next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells. Apalutamide inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.

In the United States, apalutamide received approval from the Food and Drug Administration for the treatment of patients with nmCRPC in February 2018, shortly followed by approvals in Canada, Australia, Argentina and Brazil.