Astellas receives EU approval for prostate cancer drug Xtandi

Astellas and Medivation have been granted European regulatory approval for Xtandi, their new advanced prostate cancer therapy.

The European Commission has ratified the drug as a treatment for adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

Data from the phase III Affirm trial showed that Xtandi can deliver significant overall survival benefits compared to placebo, while it was also well-tolerated, with few side effects.

Xtandi was approved and launched in the US last year, with this new EU decision following a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use in April 2013.

Johann de Bono, professor of experimental cancer medicine at London's Institute of Cancer Research, 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."

This comes after the firm received European approval for Betmiga – a new therapy for overactive bladder – earlier this year.