| 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, 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]
Medical use
[edit]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
[edit]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
[edit]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
[edit]Legal status
[edit]Axatilimab was approved for medical use in the United States in August 2024.[2][4]
Names
[edit]Axatilimab is the international nonproprietary name.[5]
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.
- ^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
- ^ "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
