# Futibatinib

Source: https://onco.cc/drugs/futibatinib/  
OnCo record `futibatinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Futibatinib is a covalent FGFR inhibitor for FGFR2-fusion bile duct cancer, with the highest response rate of the first-generation drugs.

## Summary

Futibatinib is an irreversible inhibitor of FGFR1-4 that binds covalently to a cysteine in the kinase P-loop, a mechanism that retains activity against some resistance mutations that defeat reversible FGFR inhibitors. It is used in previously treated intrahepatic cholangiocarcinoma with an FGFR2 fusion or rearrangement. FOENIX-CCA2 (NEJM 2023) showed an ORR of 42%, median PFS of 9.0 months and median OS of 21.7 months, the highest response rate of the first-generation FGFR drugs. Accelerated approval followed in September 2022 (EMA 2023) at 20 mg daily continuously; hyperphosphataemia is near universal (85%, 30% grade 3 or higher). Whether it should be preferred over pemigatinib, and how to treat acquired FGFR2 kinase-domain mutations, are open questions now addressed by agents such as tinengotinib. For a newcomer, futibatinib is the covalent FGFR pill for bile duct cancer.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Lytgobi
- Modality: Small-molecule irreversible kinase inhibitor (FGFR1-4)
- Mechanism: Irreversible covalent binder of the FGFR kinase P-loop cysteine.
- Approvals: US 2022: Previously treated FGFR2-fusion/rearranged intrahepatic cholangiocarcinoma (accelerated); EU 2023: Same; UK 2024: Locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement after at least one systemic treatment; NICE TA1005 recommended 11 September 2024 as an alternative to pemigatinib
- Dosing: Oral; 20 mg daily continuously
- Toxicity (grade 3+): Hyperphosphataemia 30%

## Notes

- Gallbladder cancer: the FDA indication is intrahepatic cholangiocarcinoma with an FGFR2 fusion or rearrangement (Lytgobi label), so futibatinib has no licensed or trial role in gallbladder cancer.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Futibatinib
- NEJM 2023: https://www.nejm.org/doi/full/10.1056/NEJMoa2206834
- NICE TA1005: futibatinib for previously treated FGFR2 fusion or rearrangement cholangiocarcinoma (11 September 2024): https://www.nice.org.uk/guidance/ta1005

## Connected records

- biomarkers: [FGFR2 fusion or rearrangement](https://onco.cc/biomarkers/fgfr2-fusion-rearrangement/)
- cancers: [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [FGFR1](https://onco.cc/targets/fgfr1/), [FGFR2](https://onco.cc/targets/fgfr2/)
- companies: [Taiho Pharmaceutical (Otsuka)](https://onco.cc/companies/taiho/)
- terms: [FGFR2 fusions and rearrangements](https://onco.cc/terms/fgfr2-fusion/)
- trials: [FOENIX-CCA2](https://onco.cc/trials/foenix-cca2/), [Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer](https://onco.cc/trials/nct07710885/), [Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.](https://onco.cc/trials/nct06506955/), [Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer](https://onco.cc/trials/nct07745296/), [Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors](https://onco.cc/trials/nct05945823/), [SAFIR-ABC10](https://onco.cc/trials/safir-abc10/)
- ideas: [ctDNA-guided switching among FGFR inhibitors](https://onco.cc/ideas/idea-btc-ctdna-fgfr-resistance/)
- pathways: [FGF / FGFR signalling](https://onco.cc/pathways/fgfr-signalling/), [Proteoglycans in cancer](https://onco.cc/pathways/proteoglycans-in-cancer/)
- drugs: [Infigratinib](https://onco.cc/drugs/infigratinib/)

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