30 January 2024 - Today, Astellas Pharma Canada announced that Health Canada has approved a supplemental new drug application for Xtandi (enzalutamide) in a new prostate cancer treatment setting.
With this approval, Xtandi becomes the first and only androgen receptor pathway inhibitor approved for use with or without a GnRH analogue in patients with non-metastatic castration sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
Health Canada granted a priority review of Xtandi in non-metastatic castration sensitive prostate cancer, which was further expedited as a result of Xtandi's inclusion in the Project Orbis initiative.