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Medinews
23 Agosto 2019

FDA Approves Darolutamide for Nonmetastatic CRPC

July 31, 2019 – The FDA has approved darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer. The approval of the androgen receptor inhibitor is based on data from the phase III ARAMIS trial, in which darolutamide in combination with androgen deprivation therapy (ADT) led to a 59% reduction in the risk of metastases or death compared with placebo/ADT in this patient population (HR, 0.41; 95% CI, 0.34-0.50; 2-sided, P <.0001) ... (leggi tutto)

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