Astellas receives EU approval for new Xtandi prostate cancer indication

Astellas has announced that its cancer drug Xtandi has been approved by the European Commission for use in a new indication.

The drug has been deemed suitable for use in 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 whom chemotherapy is not yet clinically indicated.

Data from the phase III Prevail trial, which demonstrated that Xtandi improves outcomes for men with advanced prostate cancer who have not received chemotherapy, was used to support the application.

The enzalutamide-based therapy was originally approved in Europe in June 2013 for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy.

Dr Professor Bertrand Tombal, chairman of the urology division at the Universite Catholique de Louvain and European principal investigator for the Prevail trial, said: "The decision from the European Commission to approve enzalutamide, an effective and well-tolerated alternative to chemotherapy, is a very important milestone for men with prostate cancer that has advanced."

Xtandi was recommended for NHS use in its original indication by the National Institute for Health and Care Excellence earlier this year.