Astellas files for wider use of prostate cancer drug Xtandi in Europe

3 April 2014

Japanese drug major Astellas Pharma (TSE:4503) has submitted a variation to amend the Marketing Authorization Application for Xtandi (enzalutamide) 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 and in whom chemotherapy is not yet clinically indicated.

Enzalutamide is currently approved in Europe for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel chemotherapy. Astellas and partner Medivation (Nasdaq: MDVN) filed for a similar extension with the US Food and Drug Administration last month (The Pharma Letter March 18).

This announcement follows presentation of the Phase III data for the PREVAIL trial at the American Society of Clinical Oncology (ASCO) 2014 Genitourinary (GU) Cancers Symposium in San Francisco in January.

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