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]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | CSF-1R |
| Clinical data | |
| Trade names | Niktimvo |
| Other names | axatilimab-csfr |
| AHFS/Drugs.com | Niktimvo |
| License data |
|
| Routes of administration | Intravenous |
| Drug class | Antineoplastic |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6568H10092N1696O2052S48 |
| Molar mass | 147185.68 g·mol−1 |
Axatilimab was approved for medical use in the United States in August 2024.[1][2]
Medical use
editAxatilimab 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
editThe 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
editEfficacy 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
editLegal status
editAxatilimab was approved for medical use in the United States in August 2024.[2][3]
Names
editAxatilimab is the international nonproprietary name.[4]
References
edit- ^ a b c d e f "Niktimvo- axatilimab-csfr injection". DailyMed. 16 August 2024. Retrieved 5 September 2024.
- ^ a b c d e f "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.
This article incorporates text from this source, which is in the public domain.
- ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
- ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.
External links
edit- 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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