XtandiTM (enzalutamide capsules) is now available in Canada. Health Canada approved Xtandi for the treatment of patients with metastatic castration-resistant prostate cancer, or mCRPC, who have received prior docetaxel therapy (chemotherapy medication). The announcement was made today by Astellas Pharma Canada, Inc., the Canadian subsidiary of Tokyo-based Astellas Pharma, Inc. Prostate cancer is the most common cancer to affect Canadian men, generally 40 years of age and older, with one in seven developing the disease in their lifetime. Most often, initial presentation of the disease may be asymptomatic or show minimal symptoms. However, approximately 10-20 per cent of cases will present with metastatic disease and another 33 per cent with early stage disease will go on to develop metastatic disease. The efficacy and safety of Xtandi were assessed in a randomized, placebo-controlled, multinational phase III clinical trial, called AFFIRM, that included eleven Canadian trial sites across the country. A total of 1,199 patients with mCRPC who had previously received docetaxel were randomized 2:1 to receive either Xtandi orally at a dose of 160 mg once daily (N = 800) or placebo (N = 399). Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizure were excluded from the clinical trial. The primary endpoint of the trial was overall survival.
