Alpha1H has received regulatory approval from the European Medicines Agency for its phase III clinical study of the therapy in bladder cancer. The approval represents a milestone for the clinical development of Alpha1H and provides a clear regulatory path toward a potential future marketing application in Europe.
The phase III XPORT-EC-042 trial, evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer, did not meet its primary endpoint of progression free survival.
