# Pemigatinib

Pemigatinib (Pemazyre, Incyte Biosciences Distribution 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; After at least one prior line of systemic therapy |

## Products

### Pemazyre

- Company: Incyte Biosciences Distribution B.V.
- Target: FGFR kinase inhibitor
- Class: Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
- ATC: L01EN02
- EU approval: 26 Mar 2021
- Label revised: 17 Mar 2026
- Status: conditional approval, orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/pemazyre-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/pemazyre-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/pemazyre

Mechanism (SmPC section 5.1): Inhibits FGFR1, 2, and 3 phosphorylation and signalling, decreasing cell viability in cells expressing FGFR genetic alterations.

## 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)

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/pemigatinib