{"entity":{"id":"axatilimab","kind":"drug","name":"Axatilimab","aka":["axatilimab-csfr"],"tldr":"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.","summary":"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.","status":"approved","asOf":"2026-10-10","links":[{"label":"FDA approval and indication","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axatilimab-csfr-chronic-graft-versus-host-disease"},{"label":"Current Niktimvo label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb6dba23-e7a6-4765-a1e6-b9e277ce0381"},{"label":"Investigational breast combination NCT06488378","url":"https://clinicaltrials.gov/study/NCT06488378"}],"tags":[],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":["csf1r"],"drugs":[],"companies":["syndax","incyte"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06488378"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Niktimvo","modality":"Monoclonal antibody","supportive":true,"mechanism":"Blocks colony-stimulating factor 1 receptor (CSF1R), affecting CSF1-dependent monocytes and macrophages. Its breast-cancer use with olaparib is investigational.","approvals":[{"region":"US","year":2024,"indication":"Chronic graft-versus-host disease after failure of at least two prior systemic lines in adults and pediatric patients weighing at least 40 kg","note":"FDA approval is for chronic GVHD, not breast cancer."}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/axatilimab/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"target":[{"id":"csf1r","kind":"target","name":"CSF1R","route":"/targets/csf1r/"}],"company":[{"id":"incyte","kind":"company","name":"Incyte","route":"/companies/incyte/"},{"id":"syndax","kind":"company","name":"Syndax Pharmaceuticals","route":"/companies/syndax/"}],"trial":[{"id":"nct06488378","kind":"trial","name":"Axatilimab and olaparib in BRCA/PALB2-associated metastatic breast cancer","route":"/trials/nct06488378/"}]}}