The application was filed by Astellas with the Ministry of Health, Labour and Welfare in Japan.
Oral androgen receptor inhibitor enzalutamide is designed to inhibit multiple steps in the androgen receptor signaling pathway, thereby decreasing the cancer cell growth and inducing induce cancer cell death (apoptosis).
Results from the global Phase 3 trial (the AFFIRM trial) and a Phase 1-2 trial conducted in Japan were included in the application.
The AFFIRM trial is a multi-country, double-blind, placebo-controlled study in which advanced castration-resistant prostate cancer patients who received prior docetaxel-based chemotherapy have participated.
Patients with advanced castration-resistant prostate cancer were enrolled in Phase 1 of the Phase 1-2 trial, while patients with advanced castration-resistant prostate cancer who had received docetaxel therapy were enrolled in Phase 2.