FDA grants priority review to Jakafi which is filed for acute graft-versus-host-disease.- Incyte Corp.

The FDA has accepted for Priority Review its supplemental New Drug Application (sNDA) for Jakafi(ruxolitinib), from Incyte Corp., for the treatment of patients with acute graft-versus-host-disease (GVHD) 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 GVHD who have had an inadequate response to corticosteroids. Topline results from this ongoing trial demonstrated an overall response rate of 55 percent (n=39/71) at Day 28, the primary endpoint. In addition, the best overall response rate was 73 percent (n=52/71).

Comment: If approved, ruxolitinib will be the first and only treatment available in the U.S. for patients with acute GVHD who have not responded adequately to corticosteroid therapy. The FDA previously granted ruxolitinib Breakthrough Therapy Designation for the treatment of acute GVHD, which is designed to expedite the development and review of drugs for serious conditions that have shown encouraging early clinical results and may demonstrate substantial improvements over available medicines. Additionally, the FDA has granted ruxolitinib Orphan Drug Designation for the treatment of GVHD.