Astellas bids to broaden label for Xtandi in Europe

16 March 2018

Astellas Pharma (TYO: 4503) says the European Medicines Agency (EMA) has commenced reviewing its application to broaden the label for its non-steroidal antiandrogen therapy Xtandi (enzalutamide).

The Japanese drugmaker acquired the rights to the treatment as part of a 2009 collaboration with Medivation worth up to $765 million. Medivation was bought by Pfizer (NYSE: PFE) last year for $14 billion.

Astellas, which hopes to market the therapy in Europe as a treatment for patients with non-metastatic castration-resistant prostate cancer (CRPC), supported its application with results from the Phase III PROSPER trial.

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