Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 10/12/2025

FGFR Inhibitors in Advanced Gallbladder Carcinoma

Introduction to FGFR Inhibitors

  • The European Society for Medical Oncology (ESMO) and the European Association for the Study of the Liver (EASL) guidelines make strong recommendations for FGFR inhibitors specifically in cholangiocarcinoma with FGFR2 fusions, not gallbladder cancer 3, 6, 4, 5
  • The American Society of Clinical Oncology (ASCO) recommends obtaining comprehensive genomic profiling before or during first-line chemotherapy to identify actionable alterations in patients with advanced gallbladder carcinoma 1, 2

FGFR Inhibitor Efficacy

  • Pemigatinib has an overall response rate (ORR) of 35.5%, median progression-free survival (PFS) of 6.9-9.0 months, and median overall survival (OS) of 12.2-21.7 months in patients with cholangiocarcinoma and FGFR2 fusions 3, 7, 4, 5
  • Infigratinib has an ORR of 23.1%, median PFS of 6.9-9.0 months, and median OS of 12.2-21.7 months in patients with cholangiocarcinoma and FGFR2 fusions 3, 7, 4, 5
  • Futibatinib has an ORR of 41.7%, median PFS of 6.9-9.0 months, and median OS of 12.2-21.7 months in patients with cholangiocarcinoma and FGFR2 fusions 3, 7, 4, 5

Patient Selection and Treatment Priorities

  • Patients with advanced gallbladder carcinoma should undergo comprehensive genomic profiling to identify actionable alterations, such as HER2 amplification, FGFR2 fusions/rearrangements, IDH1 mutations, BRAF V600E mutations, and MSI-H/dMMR 1, 2
  • The National Comprehensive Cancer Network (NCCN) recommends prioritizing molecular targets in the following order: HER2 amplification, FGFR2 fusions/rearrangements, IDH1 mutations, BRAF V600E mutations, and MSI-H/dMMR 1, 2
  • The ESMO guidelines recommend considering pertuzumab-trastuzumab for patients with HER2 amplification, with an ORR of 23%, median PFS of 4 months, and median OS of 10.9 months 1, 2

Key Considerations and Pitfalls

  • The EASL guidelines emphasize the importance of not assuming gallbladder carcinoma and cholangiocarcinoma are interchangeable, as they have different molecular profiles and treatment priorities 1, 2
  • The ASCO guidelines recommend not using FGFR inhibitors without documented FGFR2 fusions/rearrangements, as other FGFR alterations show no meaningful benefit 7, 4, 5, 8
  • The NCCN guidelines recommend not delaying molecular profiling, as it is essential for guiding second-line treatment decisions 1, 9, 2

REFERENCES

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