Axatilimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | CSF-1R |
| Clinical data | |
| Trade names | Niktimvo |
| Other names | axatilimab-csfr |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624043 |
| License data |
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| 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]
The most common side effects include infections;[2] increased blood level of liver enzymes;[2] decreased blood level of phosphate;[2] low red blood cell count (anemia);[2] muscle, bone, or joint pain;[2] increased blood level of pancreatic enzymes;[2] low energy;[2] increased blood level of calcium;[2] increased blood level of a muscle enzyme;[2] increased blood level of a bone enzyme;[2] nausea;[2] headache;[2] diarrhea;[2] cough;[2] fever;[2] shortness of breath;[2] and infusion related reactions.[2] Infusion-related reactions are common and can be serious.[2]
Axatilimab was approved for medical use in the United States in August 2024.[1][3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[4]
- ^ a b c d e "Niktimvo- axatilimab-csfr injection". DailyMed. 16 August 2024. Retrieved 5 September 2024.
- ^ a b c d e f g h i j k l m n o p q r Cite error: The named reference
FDA snapshotwas invoked but never defined (see the help page). - ^ "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.