OnCo
drugsProductApproved2025

Vimseltinib

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.

MOTION: ORR 40% vs 0% at week 25; improvements in range of motion, pain and function; no liver toxicity signal of the kind that limited pexidartinib. Approved 14 February 2025. Deciphera/Ono.

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Vimseltinib
PubChem
Modality
Small-molecule kinase inhibitor (CSF1R)
Mechanism
Switch-control inhibitor of CSF1R; TGCT is driven by CSF1 overexpression (COL6A3-CSF1 translocation) recruiting CSF1R+ macrophages.
Brand / code
Romvimza
Dosing & schedule
Route
Oral
Schedule
30 mg twice weekly
Monitoring
Liver enzymes, CPK, cholesterol, periorbital oedema
Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). FDA-approved February 2025.

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.

Assistance programmes

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

Not appraisedSearch NICE
Notes
No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
NHS England
Not routinely funded

Sources: NICE search: vimseltinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 14 Feb 2025ApprovalUS

    MOTION source

Approvals

RegionYearIndication
US2025Symptomatic tenosynovial giant cell tumour where surgery would worsen function or cause severe morbidity

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Periorbital oedema
45%
Fatigue
33%
Increased CPK
28%
Pruritus
28%

MOTION. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
3 studies1 recruiting2 Phase 21 Phase 3
Search “Vimseltinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Vimseltinib
intervention: Vimseltinib
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend7 papers in the last 12 months0% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Vimseltinib" OR ABSTRACT:"Vimseltinib" OR TITLE:"Romvimza" OR ABSTRACT:"Romvimza") 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 Vimseltinib, not a curated reading list.

Connected

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