{"entity":{"id":"lirafugratinib","kind":"drug","name":"Lirafugratinib","aka":[],"tldr":"An oral FGFR2 inhibitor approved in September 2026 for bile duct cancer whose tumour carries an FGFR2 fusion or rearrangement, after earlier treatment.","summary":"Lirafugratinib (RLY-4008, Lyrfigtu) is an FGFR2-selective inhibitor from Elevar Therapeutics. The US Food and Drug Administration approved it on 23 September 2026 for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma whose tumour harbours an FGFR2 gene fusion or other rearrangement, on the REFOCUS study. Selectivity for FGFR2 is the design claim: the earlier pan-FGFR inhibitors are dose-limited by the raised phosphate that follows FGFR1 inhibition.","status":"approved","asOf":"2026-09-11","links":[{"label":"FDA: approval of lirafugratinib","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lirafugratinib-previously-treated-unresectable-locally-advanced-or-metastatic"},{"label":"ClinicalTrials.gov: trials of Lirafugratinib","url":"https://clinicaltrials.gov/search?intr=RLY-4008"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":["fgfr2"],"drugs":[],"companies":["elevar-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07359820"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"brand":"Lyrfigtu","code":"RLY-4008","modality":"Small-molecule FGFR2 inhibitor","mechanism":"Oral inhibitor selective for FGFR2 over the other FGFR family members, which is the point: pan-FGFR inhibitors are limited by the hyperphosphataemia that comes from hitting FGFR1.","approvals":[{"region":"US","year":2026,"indication":"Previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026-09-23","type":"approval","region":"US","note":"Previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement (REFOCUS)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lirafugratinib-previously-treated-unresectable-locally-advanced-or-metastatic"}]},"route":"/drugs/lirafugratinib/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"}],"target":[{"id":"fgfr2","kind":"target","name":"FGFR2","route":"/targets/fgfr2/"}],"company":[{"id":"elevar-therapeutics","kind":"company","name":"Elevar Therapeutics (HLB)","route":"/companies/elevar-therapeutics/"}],"trial":[{"id":"nct07359820","kind":"trial","name":"A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement","route":"/trials/nct07359820/"}]}}