Jakafi Receives New Indication to Treat Graft-Versus-Host Disease
May 24, 2019 – The U.S. FDA has approved a new indication for Jakafi® (ruxolitinib), manufactured by Incyte. It is now indicated to treat steroid-refractory acute graft-versus-host disease (GVHD) in patients who are at least 12 years of age. Steroid-refractory GVHD does not respond to standard steroid therapy.
Graft-versus-host disease is a potentially serious complication that can occur following an allogenic transplant, in which a patient receives healthy stem cells from a donor. The condition occurs when the donor’s cells mistake the recipient’s healthy cells for foreign bodies and attack them. About half of all patients who develop acute GVHD do not respond adequately to treatment with steroids. Steroid-refractory acute GVHD can become severe, with a one-year mortality rate of approximately 70%.
In a clinical trial, the overall response rate of patients treated with Jakafi was 59%, with a complete response rate of 31%. Recommended dosing under the new indication is 5mg taken by mouth twice a day.
Jakafi first received FDA approval in 2011, and is also indicated to treat myelofibrosis and polycythemia vera.