Some good news for my European brothers, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adapted a positive opinion in support of the label expansion of enzalutamide (XTANDI) to include the treatment of men with metastatic castrate resistant prostate cancer (MCRPC) who are asymptomatic or mildly symptomatic after the failure of androgen therapy (ADT) in whom chemotherapy is not yet clinically indicated.
CHMP’s decision is driven by the positive phase 3 results of the Prevail trial where Xtandi reduced the risk of death by 29% compared to placebo. Additionally, men who were treated with Xtandi had a 17 month delay in time to their initiating chemotherapy over the placebo group.
In normal circumstances the actual decision by the European Commission usually takes 60 days from the release of CHMP’s opinion. Once this last hurdle is cleared we should finally see Xtandi available in Europe.
It is good to see that Europe will catch up and this vital treatment be made available to men prior to their having chemotherapy.
Joel T Nowak, M.A., M.S.W.