Astellas submits prostate cancer drug for EU approval

Astellas and partner Medivation have announced that their new prostate cancer therapy enzalutamide has been submitted for approval by the European Medicines Agency.

The companies have filed a marketing authorisation application for the drug, which is intended for the treatment of men with metastatic castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

This application is based on positive clinical trial data from the phase III Affirm trial supporting the safety and efficacy of the compound, which was formerly known as MDV3100.

A new drug application has also been submitted for enzalutamide in the US, where a priority review of the product has been requested by the manufacturers.

Earlier this month, Astellas announced the European debut of Dificlir, a new treatment for Clostridium difficile infections developed in collaboration with Optimer Pharmaceuticals.

The launch has been welcomed by UK medical experts as a development that will help reduce the burden placed on the NHS by recurring cases of the infection.