The investigational therapy enzalutamide (MDV3100) is now available across Europe through a Named Patient Programme. The a novel, oral androgen-receptor signalling inhibitor, will be available to men with metastatic castrateresistant prostate cancer previously treated with docetaxel chemotherapy who meet the eligibility criteria and whose physician determines that there is no other suitable therapy. A Named Patient Programme is a compassionate use programme that provides controlled access to investigational medicines prior to their regulatory approval or launch. They are designed to support early access to treatments that have demonstrated positive results during clinical trials for patients who have no alternative treatment options available to them. Regulatory submission for enzalutamide has been fled in the US and is underway for Europe, based on the results of the phase III AFFIRM study which was halted early by the Independent Data Monitoring Committee overseeing the study due to the positive benefts seen. In the phase III AFFIRM trial, enzalutamide was generally well tolerated. Common side effects observed more frequently in enzalutamide as compared with placebo-treated patients included fatigue, diarrhoea and hot flush. Seizure was reported in <1% of enzalutamide-treated patients. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the enzalutamide group than in the placebo group.