Incyte announced that the Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Jakafi (ruxolitinib) for the treatment of patients with acute graft-versus-host-disease (GVHD) who have had inadequate response to corticosteroids.

The sNDA included data from the REACH1 study (N=71) which evaluated ruxolitinib in combination with corticosteroids in patients with steroid-refractory acute GVHD. Results showed an overall response rate of 55% at day 28 (primary endpoint) and a best overall response rate of 73%. 

Jakafi, a first-in-class JAK1/JAK2 inhibitor, is currently approved to treat patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. It is also indicated for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF. 

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“If approved, ruxolitinib will be the first and only treatment available in the US for patients with acute GVHD who have not responded adequately to corticosteroid therapy,” stated Steven Stein, MD, Chief Medical Officer, Incyte. 

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