# Futibatinib

Futibatinib (Lytgobi, Taiho Pharma Netherlands B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: FGFR (1).

## Approved indications

### Biliary tract cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| FGFR2 fusion | Monotherapy | 2nd line, advanced | Cholangiocarcinoma only; Progressed after at least one prior line of systemic therapy |

## Products

### Lytgobi

- Company: Taiho Pharma Netherlands B.V.
- Target: Irreversible FGFR 1-4 inhibitor
- Class: Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
- ATC: L01EN04
- EU approval: 4 Jul 2023
- Label revised: 29 Oct 2025
- Status: conditional approval
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/lytgobi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/lytgobi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/lytgobi

Mechanism (SmPC section 5.1): Futibatinib is a kinase inhibitor that irreversibly inhibits FGFR 1, 2, 3, and 4 by covalent binding, blocking constitutive FGFR signalling.

## Label wording

- **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/drugs/futibatinib