European Commission approves Astellas' XTANDI as first novel hormone therapy for high-risk prostate cancer in adult men.
Astellas' XTANDI (Enzalutamide) has been granted European Commission approval to treat high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer in adult men, marking the first novel hormone therapy available in the EU. XTANDI can be given alone or in combination with androgen deprivation therapy. This approval is based on the positive Phase 3 EMBARK study, which showed XTANDI reduced the risk of metastasis or death.
April 23, 2024
5 Articles