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Axatilimab
Monoclonal antibody From Wikipedia, the free encyclopedia
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Axatilimab, sold under the brand name Niktimvo, is a monoclonal antibody used for the treatment of chronic graft-versus-host disease.[1] It is a blocker of the colony stimulating factor-1 receptor.[1] It is given by injection into a vein.[1]
Axatilimab was approved for medical use in the United States in August 2024.[1][2] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[3]
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Medical use
Axatilimab is indicated for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in people weighing at least 40 kilograms (88 lb).[1][2]
Adverse effects
The most common adverse reactions include increased aspartate aminotransferase (AST), infection (pathogen unspecified), increased alanine aminotransferase (ALT), decreased phosphate, decreased hemoglobin, viral infection, increased gamma glutamyl transferase (GGT), musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increased creatine phosphokinase (CPK), increased alkaline phosphatase (ALP), nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.[2]
History
Efficacy was evaluated in AGAVE-201 (NCT04710576), a randomized, open-label, multicenter trial investigating three dosages of axatilimab in people with recurrent or refractory chronic graft-versus-host disease who had received at least two lines of systemic therapy and required additional treatment.[2]
Axatilimab-csfr was granted orphan drug and fast track designations for the treatment of chronic graft-versus-host disease.[2]
Society and culture
Legal status
Axatilimab was approved for medical use in the United States in August 2024.[2][4]
Names
Axatilimab is the international nonproprietary name.[5]
References
External links
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