Posted by Michael Wonder on 25 Oct 2018
FDA grants priority review for ruxolitinib (Jakafi) as a treatment for patients with acute graft-versus-host disease
25 October 2018 - Incyte today announced that the U.S. FDA has accepted for priority review its supplemental new drug application for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host-disease who have had an inadequate response to corticosteroids.
The sNDA submission is based on data from the REACH1 study evaluating ruxolitinib in combination with corticosteroids in patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids. Top-line results from this ongoing trial demonstrated an overall response rate of 55% (n=39/71) at Day 28, the primary endpoint. In addition, the best overall response rate was 73% (n=52/71).
