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An oral FGFR2 inhibitor approved in September 2026 for bile duct cancer whose tumour carries an FGFR2 fusion or rearrangement, after earlier treatment.
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.
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. Connects to FGFR2.
1.Lirafugratinib slips into a pocket on FGFR2.
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Previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement (REFOCUS) source
| Region | Year | Indication |
|---|---|---|
| US | 2026 | Previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement |
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Query for this drug: (TITLE:"Lirafugratinib" OR ABSTRACT:"Lirafugratinib" OR TITLE:"Lyrfigtu" OR ABSTRACT:"Lyrfigtu" OR TITLE:"RLY-4008" OR ABSTRACT:"RLY-4008") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Lirafugratinib, not a curated reading list.
Shares FGFR2, Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares FGFR2, Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares FGFR2, Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares FGFR2 and the tag pipeline.
Shares Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.
Shares Biliary tract cancer (cholangiocarcinoma) and the tag pipeline.