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Axatilimab

Axatilimab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCSF-1R
Clinical data
Trade namesNiktimvo
Other namesaxatilimab-csfr
AHFS/Drugs.comNiktimvo
License data
Routes of
administration		Intravenous
Drug classAntineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
UNII
KEGG
Chemical and physical data
FormulaC6568H10092N1696O2052S48
Molar mass147185.68 g·mol−1

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]

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]

Names

Axatilimab is the international nonproprietary name.[3]

References

  1. ^ a b c d e f "Niktimvo- axatilimab-csfr injection". DailyMed. 16 August 2024. Retrieved 5 September 2024.
  2. ^ a b c d e "FDA approves axatilimab-csfr for chronic graft-versus-host disease". U.S. Food and Drug Administration. 14 August 2024. Archived from the original on 15 August 2024. Retrieved 15 August 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.
  • Clinical trial number NCT04710576 for "A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) (AGAVE-201)" at ClinicalTrials.gov


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