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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 descriptionPlace of product in therapyApproaches to treatmentCurrent treatment options and standard of care

Irreversible FGFR inhibitors

2 evidence topics · 2 sources

Futibatinib: FOENIX-CCA2 phase 2 trial

“A total of 43 of 103 patients (42%; 95% confidence interval, 32 to 52) had a response, and the median duration of response was 9.7 months.” (opens the source at this quote in a new tab)

“At a median follow-up of 17.1 months, the median progression-free survival was 9.0 months and overall survival was 21.7 months.” (opens the source at this quote in a new tab)

“Common treatment-related grade 3 adverse events were hyperphosphatemia (in 30% of the patients), an increased aspartate aminotransferase level (in 7%), stomatitis (in 6%), and fatigue (in 6%).” (opens the source at this quote in a new tab)

“Overall, treatment-related adverse events led to dose interruptions in 52 patients (50%) and dose reductions in 56 patients (54%).” (opens the source at this quote in a new tab)

Futibatinib after progression on reversible FGFR inhibitors

“Here, we report that the irreversible pan-FGFR inhibitor, TAS-120, demonstrated efficacy in four patients with FGFR2-fusion-positive ICC who developed resistance to BGJ398 or Debio1347. Examination of serial biopsies, circulating tumor DNA (ctDNA), and patient-derived ICC cells revealed that TAS-120 was active against multiple FGFR2 mutations conferring resistance to BGJ398 or Debio1347.” (opens the source at this quote in a new tab)

“Our findings suggest that strategic sequencing of FGFR inhibitors, guided by serial biopsies and ctDNA, may prolong the duration of benefit from FGFR inhibition in patients with FGFR2 fusion-positive ICC.” (opens the source at this quote in a new tab)