FDA Grants Priority Review to Ruxolitinib for Acute Graft-Versus-Host-Disease
Posted: Friday, November 16, 2018
The U.S. Food and Drug Administration (FDA) has granted Priority Review to ruxolitinib (Jakafi), a JAK1/JAK2 inhibitor, for the treatment of patients with acute graft-versus-host-disease who have had an inadequate response to corticosteroids. Ruxolitinib received FDA approval for the treatment of people with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
The supplemental new drug application submission is based on data from the REACH1 study (ClinicalTrials.gov identifier NCT02953678), which is evaluating ruxolitinib in combination with corticosteroids in patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids. The results from this ongoing trial demonstrated an overall response rate of 55% at day 28, the primary endpoint. In addition, the best overall response rate was 73%.
