ESMO guideline

FGFR inhibitors are now recommended by ESMO1


The European Society for Medical Oncology (ESMO) Clinical Practice Guidelines now recommend the use of approved fibroblast growth factor receptor (FGFR) inhibitors (such as PEMAZYRE) for the treatment of patients with cholangiocarcinoma (CCA) harbouring FGFR2 fusions whose disease has progressed after ≥1 prior line of systemic therapy.1,a

Secondary resistance mutations to reversible adenosine triphosphate-competitive FGFR inhibitors have been identified, which may be amenable to subsequent therapies with irreversible FGFR inhibitors.1

The use of RNA-based next-generation sequencing (NGS) panels that can identify fusion transcripts of known and unknown fusion partners is the preferred method of detecting FGFR2 fusions or rearrangements in patients with CCA.1

Learn more about the ESMO recommendations for CCA

Click below for more key recommendations:1

The ESMO Clinical Practice Guidelines treatment algorithm1

Chart highlighting a path from Billary tract cancer diagnosis to PEMAZYRE via FGFR2 fusion

Adapted from Annals of Oncology, Volume 34/Issue 2, Vogel A, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up, P127-401, with permission from the European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.

5-FU, 5-fluorouracil; BRAF, B-Raf proto-oncogene; dMMR, mismatch repair deficiency; ESMO, European Society for Medical Oncology; FGFR2, fibroblast growth factor receptor 2; FOLFOX, 5-fluorouracil-leucovorin-oxaliplatin; iCCA, intrahepatic cholangiocarcinoma; IDH1, isocitrate dehydrogenase 1; HER2, human epidermal growth factor receptor 2; MDT, multidisciplinary team; MSI-H, microsatellite instability-high.

aPEMAZYRE monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy;2
bEuropean Medicines Agency (EMA) and US Food and Drug Administration (FDA) approved.
cFDA approved; not EMA approved.
dAnti-programmed cell death protein 1 therapy is recommended for patients with miscrosatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR) who have not been treated with first-line immunotherapy.
eEMA approved for MSI-H/dMMR biliary tract cancer; FDA approved for all MSI-H/dMMR solid tumours.
fNot EMA approved; not FDA approved.

1. Vogel A, Bridgewater J, Edeline J, Kelley RK, Klümpen HJ, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34(2):127–40.
2. PEMAZYRE® (pemigatinib). Summary of Product Characteristics: Section 4.1 on

All references available upon request.

Learn more about PEMAZYRE® (pemigatinib):

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