Posted by Michael Wonder on 13 Sep 2023
European Medicines Agency validates type II variation for Astellas' Xtandi (enzalutamide) for treatment of non-metastatic hormone sensitive prostate cancer with high risk biochemical recurrence
13 September 2023 - Application based on results from Phase 3 EMBARK trial, which showed Xtandi plus leuprolide reduced risk of metastasis or death by 58%.
Astellas today announced that the EMA has validated its type II variation for Xtandi (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (also known as non-metastatic castration-sensitive prostate cancer) with high-risk biochemical recurrence who are unsuitable for salvage-radiotherapy.
