# FGFR in biliary tract cancer

2 EU-approved indications in biliary tract cancer need a FGFR result: pemigatinib (2nd line, advanced) and futibatinib (2nd line, advanced).

## Approved indications

### FGFR2 fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Futibatinib](https://oncolabels.com/drugs/futibatinib) (Lytgobi) | FGFR2 fusion | Monotherapy | 2nd line, advanced | Cholangiocarcinoma only; Progressed after at least one prior line of systemic therapy |
| [Pemigatinib](https://oncolabels.com/drugs/pemigatinib) (Pemazyre) | FGFR2 fusion | Monotherapy | 2nd line, advanced | Cholangiocarcinoma only; After at least one prior line of systemic therapy |

## Label wording

- **Pemigatinib** (Pemazyre), Biliary tract cancer, 2nd line, advanced: “Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/pemazyre-epar-product-information_en.pdf)
- **Futibatinib** (Lytgobi), Biliary tract cancer, 2nd line, advanced: “Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lytgobi-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/fgfr