Astellas Xtandi approved in Europe for new indication; Janssen deal update

3 December 2014

Japanese pharma major Astellas Pharma (TSE: 4503) has received European Commission approval for a variation to amend the Marketing Authorization for Xtandi (enzalutamide).

Enzalutamide is now approved for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy in whom chemotherapy is not yet clinically indicated.

The approval of the variation is based on results from the pivotal Phase III PREVAIL study which demonstrate that enzalutamide improves outcomes for men with advanced prostate cancer who have not received chemotherapy.

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