{"entity":{"id":"vimseltinib","kind":"drug","name":"Vimseltinib","aka":[],"tldr":"Vimseltinib is a pill approved in February 2025 for tenosynovial giant cell tumour, a benign but destructive joint tumour, offering an alternative to repeated surgery.","summary":"Vimseltinib is a switch-control kinase inhibitor of CSF1R. Tenosynovial giant cell tumour is driven by CSF1 overexpression from a COL6A3-CSF1 translocation, which recruits CSF1R-positive macrophages to form the tumour mass, so blocking the receptor disperses the bulk of the lesion. Taken twice weekly, it was tested in the phase 3 MOTION trial, where the ORR at week 25 was 40% versus 0% on placebo, with improvements in range of motion, pain, stiffness and function (Lancet 2024). The FDA approved it on 14 February 2025 for symptomatic TGCT where surgery would worsen function or cause severe morbidity. No liver toxicity signal of the kind that restricted pexidartinib, the first CSF1R inhibitor, was seen; periorbital oedema was the main effect; Deciphera and Ono develop it. It is a pill for a benign but destructive joint tumour that shrinks it by dispersing the immune cells it is made of.","status":"approved","asOf":"2026-09-07","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Vimseltinib"}],"tags":[],"related":[],"cancers":["sarcoma","tenosynovial-giant-cell-tumour"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":[],"companies":["deciphera"],"institutions":[],"pathways":[],"terms":[],"trials":["motion","nct03069469"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Romvimza","modality":"Small-molecule kinase inhibitor (CSF1R)","mechanism":"Switch-control inhibitor of CSF1R; TGCT is driven by CSF1 overexpression (COL6A3-CSF1 translocation) recruiting CSF1R+ macrophages.","approvals":[{"region":"US","year":2025,"indication":"Symptomatic tenosynovial giant cell tumour where surgery would worsen function or cause severe morbidity"},{"region":"EU","year":2025,"indication":"Symptomatic TGCT where surgery has been exhausted or would cause unacceptable morbidity; 17 Sep 2025"}],"mechanismSteps":[],"dosing":{"route":"Oral","schedule":"30 mg twice weekly","monitoring":"Liver enzymes, CPK, cholesterol, periorbital oedema"},"toxicity":[{"event":"Periorbital oedema","anyGradePct":45,"note":"MOTION"},{"event":"Fatigue","anyGradePct":33},{"event":"Increased CPK","anyGradePct":28},{"event":"Pruritus","anyGradePct":28}],"access":[],"regulatoryEvents":[{"date":"2025-02-14","type":"approval","region":"US","note":"MOTION","source":"https://www.cancernetwork.com/view/fda-approves-vimseltinib-in-tenosynovial-giant-cell-tumor"}]},"route":"/drugs/vimseltinib/","neighbours":{"cancer":[{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"},{"id":"tenosynovial-giant-cell-tumour","kind":"cancer","name":"Tenosynovial giant cell tumour (TGCT)","route":"/cancers/tenosynovial-giant-cell-tumour/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"company":[{"id":"deciphera","kind":"company","name":"Deciphera Pharmaceuticals (Ono)","route":"/companies/deciphera/"}],"trial":[{"id":"motion","kind":"trial","name":"MOTION","route":"/trials/motion/"},{"id":"nct03069469","kind":"trial","name":"Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor","route":"/trials/nct03069469/"}],"target":[{"id":"col6a3","kind":"target","name":"COL6A3","route":"/targets/col6a3/"},{"id":"csf1","kind":"target","name":"CSF1","route":"/targets/csf1/"},{"id":"csf1r","kind":"target","name":"CSF1R","route":"/targets/csf1r/"}],"pathway":[{"id":"myeloid-suppression-axis","kind":"pathway","name":"Myeloid suppression: TAMs, MDSCs & don't-eat-me signals","route":"/pathways/myeloid-suppression-axis/"}]}}