Astellas files for new EU approval of prostate cancer drug Xtandi

Astellas is seeking an expanded European indication for Xtandi, its clinically-proven therapy for prostate cancer.

A variation to amend the marketing authorisation application for the product has been submitted by Astellas to allow Xtandi to be used for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in who cannot receive chemotherapy.

Currently, the drug is approved in Europe for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel chemotherapy, but phase III clinical trial data has shown its potential efficacy in this new indication.

The company will work with partner Medivation to secure the relevant European Medicines Agency approval.

Dr Ayad Abdulahad, senior vice-president for medical affairs and health economics at Astellas, said: "Oncology is a growing area of focus for Astellas and we are committed to developing and
bringing to market medicines which meet current unmet medical needs."

This comes after the company announced the launch of a new regenerative medicine business unit last week.