Erleada Approved in Europe for Castration-resistant Prostate Cancer Patients at High Risk of Metastasis

Erleada Approved in Europe for Castration-resistant Prostate Cancer Patients at High Risk of Metastasis
The European Commission has approved the use of Erleada (apalutamide) for the treatment of men with castration-resistant prostate cancer at high risk of developing metastasis, announced Janssen Oncology, the therapy's developer. The decision follows promising data from a Phase 3 trial (NCT01946204), called SPARTAN, where Erleada treatment reduced the risk of cancer spreading by 72% without affecting quality of life scores. In the U.S., the medicine was approved for a similar indication in February 2018. “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,” Ivo Winiger-Candolfi, MD, oncology solid tumor therapy area lead for Europe, the Middle East, and Africa at Janssen affiliate Cilag GmbH International, said in a press release. “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,” he added. Metastasis is a major cause of complications and death among men with prostate cancer, and investigators have been focusing on the prevention of metastasis in men at risk, which may significantly extend their lives and improve their quality of life. Erleada is an oral agent that prevents the binding of testosterone to the androgen receptor, blocking signals that prostate cancer cells require to grow and proliferate. SPARTAN included 1,207 patients with non-metastatic, castration-resistant prostate cancer whose prost
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