| 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 nameNiktimvo, is amonoclonal antibody used for the treatment of chronicgraft-versus-host disease.[1] It is a blocker of thecolony stimulating factor-1 receptor.[1] It is given byinjection into a vein.[1]
Axatilimab was approved for medical use in the United States in August 2024.[1][2] The USFood and Drug Administration (FDA) considers it to be afirst-in-class medication.[3]
Axatilimab isindicated 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]
The most common adverse reactions include increasedaspartate aminotransferase (AST), infection (pathogen unspecified), increasedalanine aminotransferase (ALT), decreased phosphate, decreased hemoglobin, viral infection, increased gamma glutamyl transferase (GGT), musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increasedcreatine phosphokinase (CPK), increased alkaline phosphatase (ALP), nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.[2]
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 grantedorphan drug andfast track designations for the treatment of chronic graft-versus-host disease.[2]
Axatilimab was approved for medical use in the United States in August 2024.[2][4]
Axatilimab is theinternational nonproprietary name.[5]
This article incorporates text from this source, which is in thepublic domain.
