CHICAGO, IL / ACCESSWIRE / August 15, 2024 / The American Society for Transplantation and Cellular Therapy (ASTCT) applauds the U.S. Food and Drug Administration's (FDA) approval of axatilimab-csfr (Niktimvo, Incyte Corporation), a significant new therapy for patients suffering from chronic graft-versus-host disease (cGVHD). This approval represents a major advancement in the treatment of this severe and often debilitating condition, which affects many individuals following allogeneic stem cell transplantation.
Efficacy for Niktimvo was evaluated in the AGAVE-201 (NCT04710576) study, a randomized, open-label, multicenter trial. This study investigated three dosages of Niktimvo in both adult and pediatric patients with recurrent or refractory cGVHD who had received at least two lines of systemic therapy and required additional treatment. The trial's findings demonstrated the potential of Niktimvo to improve outcomes for this patient population.
ASTCT President, Corey Cutler, MD, MPH, who served as the co-first author of the AGAVE-201 study, expressed enthusiasm about the FDA's decision. "The approval of Niktimvo is a critical advancement in our ability to treat chronic graft-versus-host disease, particularly for patients who have exhausted other treatment options. The results from AGAVE-201 provide strong evidence of the efficacy of this new therapy, and we look forward to the availability of this compound for our patients," said Dr. Cutler.
This FDA approval was supported by the agency's use of Assessment Aid, a voluntary submission from the applicant designed to facilitate a more efficient review process. The application for Niktimvo was granted priority review, underscoring the urgent need for new therapies in this area. The drug also received Orphan Drug Designation and Fast Track Designation, reflecting its potential to address a significant unmet medical need.
ASTCT remains committed to advancing the field of transplantation and cellular therapy through research, education, and advocacy. The approval of Niktimvo marks a pivotal moment in the ongoing effort to improve outcomes for patients with cGVHD.
Healthcare professionals are encouraged to report any serious adverse events suspected to be associated with the use of Niktimvo or any other medications to the FDA's MedWatch Reporting System, either online or by calling 1-800-FDA-1088.
About The American Society for Transplantation and Cellular Therapy® (ASTCT®)
The American Society for Transplantation and Cellular Therapy (ASTCT) is an international professional society dedicated to improving the lives of blood and marrow transplant and cellular therapy patients. ASTCT represents more than 3,900 physicians, investigators, and other health care professionals from more than 45 countries. Our mission is dedicated to improving the application and success of blood and marrow transplantation and related cellular therapies. We strive to be the leading organization promoting research, education, and clinical practice in the field. For more information about ASTCT, visit www.astct.org.
Contact Information
Jayne Kramer
Marketing Manager
jkramer@astct.org
202.367.2313
SOURCE: American Society for Transplantation and Cellular Therapy® (ASTCT®)
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