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The Committee for Medicinal Products for Human Use (CHMP), which is part of the European Medicines Agency (EMA), gave a positive opinion for the new prostate cancer medicine. Erleada (apalutamide) is used for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Having the authority to grant approval for the use of Erleada (apalutamide), the European Commission will next review CHMP's positive opinion.
CHMP's positive opinion is based on the results of a clinical trial to determine the medicine's safety and efficacy. The study compared patients on Erleada (apalutamide) to a placebo group. Both patient groups had increasing amounts of antigen, foreign substances that bring on an immune response, despite receiving androgen deprivation therapy (ADT) to decrease the antigen levels. The group taking Erleada (apalutamide) while also receiving ADT were 72% less likely to die or have the cancer spread to distant organs or lymph nodes when compared to the placebo group.
Dr Ivo Winiger-Candolfi M.D. of Janssen Oncology stated, "[T]oday’s positive CHMP opinion brings us one step closer to offering patients an effective treatment option that delays the spread of their disease."