# Tenosynovial giant cell tumour

The EU has approved 1 indication of 1 drug in tenosynovial giant cell tumour. None of them needs a biomarker result.

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Vimseltinib](https://oncolabels.com/drugs/vimseltinib) (Romvimza) | None | Monotherapy | Any line | Symptomatic; clinically relevant physical function deterioration; surgical options have been exhausted or would induce unacceptable morbidity or disability |

## 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/tumours/tenosynovial-giant-cell-tumour