FDA approved axatilimab-csfr for chronic graft-versus-host disease in August 2024
Incyte's Niktimvo cleared for patients after at least two prior lines of systemic therapy failed.
The Food and Drug Administration approved axatilimab-csfr, marketed as Niktimvo by Incyte Corporation, on August 14, 2024. The drug is a colony stimulating factor-1 receptor-blocking antibody approved for treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adults.1
Chronic graft-versus-host disease is a condition that can arise following allogeneic stem cell or bone marrow transplants, in which transplanted immune cells attack the recipient's healthy tissue. The approval provides an additional treatment option for patients whose disease has not responded to earlier lines of systemic therapy.
No further details on dosing, trial results, or additional regulatory milestones for axatilimab-csfr are included in the available FDA record as of this story's date.
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