The FDA granted a new indication for ruxolitinib (Jakafi, Incyte) for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years of age and older. Ruxolitinib is the only FDA-approved treatment for this indication.
The approval was based on data from REACH1, a multicenter, open-label, single-arm study of ruxolitinib in combination with corticosteroids in patients with steroid-refractory, grade II to IV acute GVHD. Of the 71 patients in the