Press release
Incyte Announces FDA Approval of Jakafi® (ruxolitinib) for Treatment of Chronic Graft-Versus-Host Disease (GVHD)
- Jakafi is approved for treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older -
About this update from Incyte Corporation
[{"type":"text","content":"\n- Jakafi is approved for treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older\n\n- Today’s approval marks the fourth FDA-approved indication for Jakafi, which received FDA-approval in 2019 for steroid-refractory acute GVHD in adult and pediatric patients 12 years and older\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.\n\n“GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, yet there historically have been limited treatment options available beyond first-line systemic therapies,” stated Steven Stein, M.D., Chief Medical Officer, Incyte. “Incyte is proud to have contributed to the overall scientific understanding of GVHD through our REACH program, which has led to important treatment advances on behalf of patients and the medical community, including today’s approval of Jakafi for certain people who develop chronic GVHD.”\n\nThe FDA approval was based on the REACH3 study, a Phase 3, randomized, open-label, multicenter study of Jakafi in comparison to best available therapy (BAT) for treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation. The primary endpoint of overall response rate (ORR) at Week 24 (i.e., Cycle 7 Day 1) was 49.7% for Jakafi compared to 25.6% for BAT (P 35%) were anemia and thrombocytopenia. The most common nonhematologic adverse reactions (incidence ≥ 20%) were infections (pathogen not specified) and viral infection. Full results from the REACH3 study were published in the New England Journal of Medicine (NEJM).\n\n“Nearly half of the people who develop chronic GVHD do not respond adequately to steroids – the current standard of care – making this life-threatening condition particularly challenging to treat,” said Dr. Robert Zeiser, University Medical Center Freiburg, Department of Hematology, Oncology and Stem Cell Transplantation, Freiburg, Germany, the principal investigator of the REACH3 trial. “In this clinical trial, treatment with Jakafi demonstrated significantl...