Posted by Michael Wonder on 17 Nov 2023
Pfizer and Astellas' Xtandi approved by US FDA in earlier prostate cancer treatment setting
16 November 2023 - Xtandi becomes the first and only androgen receptor signalling inhibitor approved for use with or without a GnRH analog therapy in non-metastatic castration-sensitive prostate cancer.
Astellas Pharma and Pfizer today announced that the companies received an approval by the US FDA of a supplemental New Drug Application for Xtandi (enzalutamide), following FDA expedited development and review programs (priority review designation, fast track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial.
