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FGFR2 fusions occur in 10 to 15 percent of intrahepatic bile duct cancers and almost nowhere else. Pemigatinib and futibatinib are approved for them after a first chemotherapy.
FGFR2 fusions (BICC1 is the commonest partner) and other rearrangements are detected by RNA or DNA sequencing or FISH. Pemigatinib (Pemazyre, 2020) is labelled for previously treated unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test, FoundationOne CDx being the companion diagnostic; futibatinib (Lytgobi, 2022) for intrahepatic cholangiocarcinoma harbouring FGFR2 gene fusions or other rearrangements. Infigratinib's US approval was withdrawn in 2024. Acquired kinase-domain mutations (N550, V565F) drive resistance and are the target of next-generation FGFR2 inhibitors in trials.
In plain words · FGFR2 is a growth receptor fused in bile-duct cancer and overproduced in gastric cancer.
An FGFR2 fusion in bile duct cancer means pemigatinib or futibatinib, both tablets, are on label after first chemotherapy. They raise blood phosphate and can affect the eyes, so monitoring is part of treatment. Because the fusion is found in about one in eight intrahepatic cases, every patient with this cancer should have the tumour sequenced.
Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.
An FGFR2 gene fusion or other rearrangement involving the kinase domain, by DNA or RNA sequencing or FISH.
“FGFR2 fusions and select rearrangements”
FDA: List of FDA-Authorized Companion Diagnostic Devices| Threshold | Drug | Cancer | Regulator | Source |
|---|---|---|---|---|
| FGFR2 fusion or other rearrangement | Pemigatinib | Biliary tract cancer (cholangiocarcinoma) | FDA | label |
| FGFR2 gene fusion or other rearrangement | Futibatinib | Intrahepatic cholangiocarcinoma | FDA | label |
| Device | Maker | Indication and sample | Drug | PMA / 510(k) |
|---|---|---|---|---|
| FoundationOne CDx | Foundation Medicine | Cholangiocarcinoma - Tissue | Pemigatinib | P170019/S013 (04/17/2020) |
Matched on the name and aliases of the readout in the title, setting and summary of each trial; a match is a mention, not proof the readout was an entry criterion.
Shares FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx, Gene fusion, Biliary tract cancer (all types) and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.
Shares Futibatinib, FGFR2, Intrahepatic cholangiocarcinoma, Biliary tract cancer (cholangiocarcinoma).
Shares FGFR3 alteration (mutation or fusion) and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx and the tag biomarker.