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Ref Type
PMID
Authors
Title Lyrfigtu (lirafugratinib) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220425
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Lirafugratinib Lirafugratinib 17 2
Drug Name Trade Name Synonyms Drug Classes Drug Description
Lirafugratinib Lyrfigtu RLY4008|RLY 4008|RLY-4008 FGFR2 Inhibitor 24 Lyrfigtu (lirafugratinib) is a selective, irreversible FGFR2 inhibitor that blocks FGFR2 signaling, potentially lead to tumor growth inhibition (PMID: 38300868). Lyrfigtu (lirafugratinib) is FDA-approved for use in patients with previously treated advanced or metastatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 rearrange cholangiocarcinoma sensitive Lirafugratinib FDA approved Actionable In a Phase I/II trial (ReFocus) that supported FDA approval, Lyrfigtu (lirafugratinib) treatment was safe and resulted in an objetive response rate of 47% (53/114, 3 complete and 50 partial responses), a median duration of response of 11.8 mo, a meidan progression-free survival of 11.3 mo, and median overall survial of 22.8 mo in FGFR inhibitor-naive cholangiocarcinoma patients harboring FGFR2 fusions or rearrangements (J Clin Oncol 44, 2026 (suppl 2; abstr 476); NCT04526106). detail... detail...
FGFR2 fusion cholangiocarcinoma predicted - sensitive Lirafugratinib FDA approved Actionable In a Phase I/II trial (ReFocus) that supported FDA approval, Lyrfigtu (lirafugratinib) treatment was safe and resulted in an objetive response rate of 47% (53/114, 3 complete and 50 partial responses), a median duration of response of 11.8 mo, a meidan progression-free survival of 11.3 mo, and median overall survial of 22.8 mo in FGFR inhibitor-naive cholangiocarcinoma patients harboring FGFR2 fusions or rearrangements (J Clin Oncol 44, 2026 (suppl 2; abstr 476); NCT04526106). detail... detail...