Enzalutamide approved in Europe for treatment of chemotherapy-naive mCRPC

The European Commission has expanded marketing authorization for enzalutamide to include treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy and in whom chemotherapy is not yet clinically indicated.

According to a media release issued earlier this morning by Astellas Pharma, this indication is based on data from the PREVAIL trial, and follows a similar approval of enzalutamide in the USA earlier this year. However, exactly when enzalutamide may be made available for treatment of such patients in individual member countries of the European Union will depend on national regulations in those individual countries.

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