FDA Approves New Treatment for Chronic Graft-Versus-Host Disease

CHICAGO, IL / ACCESSWIRE / August 15, 2024 – The American Society for Transplantation and Cellular Therapy (ASTCT) has expressed strong support for the recent approval of axatilimab-csfr (Niktimvo) by the U.S. Food and Drug Administration (FDA). This new therapy, developed by Incyte Corporation, offers hope for patients suffering from chronic graft-versus-host disease (cGVHD), a condition that can arise after stem cell or bone marrow transplants. The efficacy of Niktimvo was assessed in the AGAVE-201 study, a randomized, open-label, multicenter trial that demonstrated its potential to enhance patient outcomes. ASTCT highlighted the significance of this approval, particularly for individuals who have not responded to existing treatment options. The FDA's decision was expedited through a priority review process, reflecting the urgent need for innovative therapies in this challenging area of medicine. ASTCT emphasized that the approval of Niktimvo represents a crucial step forward in the treatment of cGVHD, aligning with the organization's mission to advance transplantation and cellular therapy through research, education, and advocacy. The society remains dedicated to improving the lives of patients affected by blood and marrow transplants and related therapies. For more information about ASTCT and its initiatives, interested parties can visit their official website at www.astct.org. The approval of Niktimvo is seen as a pivotal moment in the ongoing efforts to enhance treatment options for patients battling chronic graft-versus-host disease.