# FGFR

3 EU-approved indications of 3 drugs need a FGFR result, in 2 tumour types, most of them in biliary tract cancer and urothelial carcinoma.

## Approved indications by tumour

### Biliary tract cancer

| 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 |

### Urothelial carcinoma

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Erdafitinib](https://oncolabels.com/drugs/erdafitinib) (Balversa) | Susceptible FGFR3 genetic alterations | Monotherapy | 2nd line, advanced | After at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting |

## Label wording

- **Erdafitinib** (Balversa), Urothelial carcinoma, 2nd line, advanced: “Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf)
- **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/biomarkers/fgfr