# Vimseltinib

Vimseltinib (Romvimza, Deciphera Pharmaceuticals (Netherlands) B.V.) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Tenosynovial giant cell tumour

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Any line | Symptomatic; clinically relevant physical function deterioration; surgical options have been exhausted or would induce unacceptable morbidity or disability |

## Products

### Romvimza

- Company: Deciphera Pharmaceuticals (Netherlands) B.V.
- Target: CSF1R kinase inhibitor
- Class: Other protein kinase inhibitors
- ATC: L01EX
- EU approval: 17 Sep 2025
- Label revised: 11 Feb 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/romvimza-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/romvimza-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/romvimza

Mechanism (SmPC section 5.1): Vimseltinib inhibits CSF1R autophosphorylation and downstream signalling, depleting CSF1R-dependent macrophages and inflammatory cells to exert anti-tumour effects.

## Label wording

- **Vimseltinib** (Romvimza), Tenosynovial giant cell tumour, any line: “ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/romvimza-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/vimseltinib