Astellas and Medivation's Xtandi approved in EU for advanced prostate cancer

24 June 2013

Japanese drug major Astellas Pharma (TYO: 4503) European subsidiary today (June 24) received approval from the European Commission for the marketing on its drug Xtandi (enzalutamide), under development with USA-based Medication (Nasdaq: MDVN), for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

The decision follows a positive regulatory review process by the European Medicines Agency and a positive Committee for Medicinal Products for Human Use (CHMP) opinion (The Pharma Letter April 28). The drug was approved by the US Food and Drug Administration last year (TPL September 8, 2012).

On receiving marketing authorization in Europe, Astellas will provide Medivation with a $15 million milestone payment, as reflected in Astellas’ current fiscal year (from April 1, 2013 to March 31, 2014) financial forecast.

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