The European Commission has granted marketing authorisation for Xtandi, an oral prostate cancer drug developed by Astellas Pharma and US-based Medivation.
Xtandi (enzalutamide) will be available to treat men with metastic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy, a clinically well-established anti-mitotic chemotherapy.
The drug, an androgen receptor inhibitor, has been shown to improve the survival of patients by 26% when compared with a placebo and to delay the progression of disease in a phase III clinical trial involving 1,199 men.
The approval comes two months after the European Medicines Agency’s Committee for Human Medicinal Products issued a positive recommendation on the treatment.
London Institute of Cancer Research’s professor Johann de Bono said: "This is a major development in prostate cancer therapeutics that will provide an important new treatment option for patients with advanced prostate cancer following chemotherapy."
Upon receiving marketing authorisation in Europe, Astellas will pay a $15m milestone payment to Medivation, which secured approval from the US Food and Drug and Administration in August 2012 for Xtandi.
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The EC grant of the marketing authorisation applies in all European Union member states, as well as in the European Economic Area countries Iceland, Liechtenstein and Norway.
Image: The European Commission headquarters in the Berlaymont building, Brussels. Photo: courtesy of JLogan.