Posted by Michael Wonder on 23 Apr 2024
Astellas' Xtandi (enzalutamide) granted European Commission approval for use in additional recurrent early prostate cancer treatment setting
23 April 2024 - Approval is based on results from the positive Phase 3 EMBARK study which showed Xtandi alone or in combination with leuprolide reduced the risk of metastasis or death.
Astellas Pharma today announced the European Commission has approved a label extension for Xtandi (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer who are unsuitable for salvage-radiotherapy.
