# IDH1/2 in biliary tract cancer

1 EU-approved indication in biliary tract cancer needs a IDH1/2 result: ivosidenib (2nd line, advanced).

## Approved indications

### IDH1 mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Ivosidenib](https://oncolabels.com/drugs/ivosidenib) (Tibsovo) | IDH1 R132 | Monotherapy | 2nd line, advanced | Cholangiocarcinoma only; After at least one prior line of systemic therapy |

## Label wording

- **Ivosidenib** (Tibsovo), Biliary tract cancer, 2nd line, advanced: “Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tibsovo-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/biliary-tract-cancer/idh1-2