Incyte announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Jakafi (ruxolitinib) for the treatment of patients with acute graft-versus-host disease (GVHD).

Graft-versus-host disease (GVHD) is an immune-mediated disorder resulting from an interaction between donor and recipient immunity after allogeneic transplantation. GVHD could present in two forms, acute or chronic. Currently, there are no FDA approved treatment options for patients with acute GVHD. 

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Jakafi is currently indicated for the treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea, and for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

Ruxolitinib is a first-in-class JAK1/JAK2 inhibitor.

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