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Lirafugratinib (Lyrfigtu)

Previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma

Also known as RLY-4008
Regulatory submission
NDA submitted January 2026
Last updated
158 sources

Product information and disease descriptionProduct descriptionProduct information

Indication

4 evidence topics · 3 sources

Approved indication

“LYRFIGTU is indicated for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement [see Dosage and Administration (2.1)].” (opens the prescribing information at this quote)

“This NDA provides for the use of Lyrfigtu (lirafugratinib) capsule for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.” (opens the source at this quote in a new tab)

Patient selection and the absence of an FDA-authorized test

“Select patients for the treatment of locally advanced or metastatic cholangiocarcinoma with LYRFIGTU based on the presence of an FGFR2 gene fusion or rearrangement [see Clinical Studies (14)].” (opens the prescribing information at this quote)

“An FDA-authorized test for detection of FGFR2 gene fusions or other rearrangements in patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma for selecting patients for treatment with LYRFIGTU is not available.” (opens the prescribing information at this quote)

“Qualifying in-frame fusions and other FGFR2 rearrangements were predicted to have a breakpoint within intron 17/exon 18 of the FGFR2 gene leaving the FGFR2 kinase domain intact.” (opens the prescribing information at this quote)

Population in which efficacy was established

“The efficacy of LYRFIGTU was evaluated in REFOCUS (RLY-4008-101; NCT04526106), a multicenter, open-label, single-arm trial in 116 patients with unresectable or metastatic cholangiocarcinoma who were naïve to FGFR inhibitor treatment and had received prior chemotherapy or chemoimmunotherapy.” (opens the prescribing information at this quote)

Indications under development

“Elevar continues to evaluate Lyrfigtu for other indications in ongoing clinical development programs, including studies in other FGFR2-altered solid tumors. Any future indications will be subject to regulatory review and approval.” (opens the source at this quote in a new tab)