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Axatilimab targets an immune-cell signal used by macrophages. It is approved for chronic graft-versus-host disease and is being tested with olaparib in advanced breast cancer.
FDA approval on 2024-08-14 is for chronic graft-versus-host disease after failure of at least two prior systemic treatments in adults and children weighing at least 40 kg. This is not a breast-cancer approval. The June 2026 label describes CSF1R blockade and monitoring for infusion reactions and laboratory abnormalities. The recruiting phase 1b olaparib combination, NCT06488378, studies metastatic or unresectable HER2-negative breast cancer with qualifying BRCA1/2 or germline PALB2 alterations; a history of pneumonitis or ILD, or baseline evidence of either, is excluded. No comparative or postoperative efficacy is established.
Blocks colony-stimulating factor 1 receptor (CSF1R), affecting CSF1-dependent monocytes and macrophages. Its breast-cancer use with olaparib is investigational. Connects to CSF1R.
1.Axatilimab binds CSF1R.
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Chronic graft-versus-host disease after failure of at least two prior systemic lines in adults and pediatric patients weighing at least 40 kg · FDA approval is for chronic GVHD, not breast cancer. |
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Query for this drug: (TITLE:"Axatilimab" OR ABSTRACT:"Axatilimab" OR TITLE:"Niktimvo" OR ABSTRACT:"Niktimvo" OR TITLE:"axatilimab-csfr" OR ABSTRACT:"axatilimab-csfr") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Axatilimab, not a curated reading list.
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