Press release
Incyte Announces European Commission Approval of Jakavi® (ruxolitinib) as the First Post-Steroid Treatment for Acute and Chronic Graft-Versus-Host Disease
Jakavi® (ruxolitinib) is the first JAK1/2 inhibitor available for patients in Europe who previously had no approved therapies for the treatment of
About this update from Incyte Corporation
[{"type":"text","content":"\n\nJakavi® (ruxolitinib) is the first JAK1/2 inhibitor available for patients in Europe who previously had no approved therapies for the treatment of steroid-refractory graft-versus-host disease (GVHD)1,2\n\n\nIn clinical trials, Jakavi demonstrated superiority versus best available therapy in patients with steroid-refractory/dependent acute and chronic GVHD, with overall response rates of 62% vs. 39%, and 50% vs. 26% respectively2,3\n\n\nGVHD is a common and potentially life-threatening complication that arises in approximately half of patients following allogeneic stem cell transplants4\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced the European Commission (EC) has approved Jakavi® (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GVHD who have inadequate response to corticosteroids or other systemic therapies. Ruxolitinib is marketed as Jakavi by Novartis in Europe and as Jakafi® by Incyte in the United States.\n\n“With the approval of this new indication for Jakavi, patients in Europe with acute or chronic GVHD who do respond to first-line steroid therapies have a new option that could redefine treatment for their condition,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. “Unfortunately, many people who receive allogenic stem cell transplants experience GVHD, and it is our hope that this Incyte-discovered medicine will make a significant impact for this patient population.”\n\nThe approval of Jakavi follows the positive opinion granted in March 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), based on the Phase 3 REACH2 and REACH3 clinical studies in which Jakavi demonstrated superiority in overall response rate (ORR) compared to best available therapy (BAT). Results of REACH2 showed 62% ORR with Jakavi at Day 28, compared to 39% for BAT; and REACH3 demonstrated a significantly improved ORR at week 24 (50% vs. 26%) with a higher best ORR (76% vs. 60%) vs. BAT, among steroid-refractory/dependent chronic GVHD patients2,3.\n\n“Today, 30-60% of patients with GVHD do not respond to first-line steroid treatment, underscoring the need for new approaches to ensure long-term treatment goals are met,” said Robert Zeiser, M.D., University Hospital Freiburg, Department ...