{"entity":{"id":"fgfr2-fusion-rearrangement","kind":"biomarker","name":"FGFR2 fusion or rearrangement","aka":["FGFR2 fusion","FGFR2 rearrangement","FGFR2-BICC1","FGFR2::BICC1","FGFR2 fusion-positive cholangiocarcinoma","FGFR2 alteration"],"tldr":"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.","summary":"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 Infigratinib's US approval was withdrawn in 2024.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.","asOf":"2026-09-23","links":[{"label":"PEMAZYRE prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e1f2222-1d89-4e63-989c-ccebe2ab1eb4"},{"label":"LYTGOBI prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b1332a1-0581-4707-9bf6-1eccfa39bef4"}],"tags":["biomarker","fgfr"],"related":["fgfr3-alteration"],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma","biliary-tract-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pemigatinib","futibatinib","infigratinib","foundationone-cdx"],"companies":[],"institutions":[],"pathways":[],"terms":["fgfr2-fusion","gene-fusion"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"target":"fgfr2","measurement":"sequencing-variant","scoringRule":{"text":"An FGFR2 gene fusion or other rearrangement involving the kinase domain, by DNA or RNA sequencing or FISH.","quote":"FGFR2 fusions and select rearrangements","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools","sourceLabel":"FDA: List of FDA-Authorized Companion Diagnostic Devices"},"thresholds":[{"value":"FGFR2 fusion or other rearrangement","drugId":"pemigatinib","cancerId":"cholangiocarcinoma","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e1f2222-1d89-4e63-989c-ccebe2ab1eb4","quote":"for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.","status":"current"},{"value":"FGFR2 gene fusion or other rearrangement","drugId":"futibatinib","cancerId":"intrahepatic-cholangiocarcinoma","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b1332a1-0581-4707-9bf6-1eccfa39bef4","quote":"LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements","status":"current"}],"tests":["foundationone-cdx","foundationone-liquid-cdx","tempus-xt","trusight-oncology-comprehensive","caris-mi-profile"],"assays":["foundationone-cdx-panel"],"companionDiagnostics":[{"device":"FoundationOne CDx","maker":"Foundation Medicine","companyId":"foundation-medicine","drugs":["pemigatinib"],"indication":"Cholangiocarcinoma - Tissue","pma":"P170019/S013 (04/17/2020)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"forPatient":"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."},"route":"/biomarkers/fgfr2-fusion-rearrangement/","neighbours":{"biomarker":[{"id":"fgfr3-alteration","kind":"biomarker","name":"FGFR3 alteration (mutation or fusion)","route":"/biomarkers/fgfr3-alteration/"}],"cancer":[{"id":"biliary-tract-cancer","kind":"cancer","name":"Biliary tract cancer (all types)","route":"/cancers/biliary-tract-cancer/"},{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"intrahepatic-cholangiocarcinoma","kind":"cancer","name":"Intrahepatic cholangiocarcinoma","route":"/cancers/intrahepatic-cholangiocarcinoma/"}],"drug":[{"id":"foundationone-cdx","kind":"drug","name":"FoundationOne CDx / Liquid CDx","route":"/drugs/foundationone-cdx/"},{"id":"futibatinib","kind":"drug","name":"Futibatinib","route":"/drugs/futibatinib/"},{"id":"infigratinib","kind":"drug","name":"Infigratinib","route":"/drugs/infigratinib/"},{"id":"pemigatinib","kind":"drug","name":"Pemigatinib","route":"/drugs/pemigatinib/"}],"term":[{"id":"fgfr2-fusion","kind":"term","name":"FGFR2 fusions and rearrangements","route":"/terms/fgfr2-fusion/"},{"id":"gene-fusion","kind":"term","name":"Gene fusion","route":"/terms/gene-fusion/"}],"target":[{"id":"fgfr2","kind":"target","name":"FGFR2","route":"/targets/fgfr2/"}]}}