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Futibatinib is a covalent FGFR inhibitor for FGFR2-fusion bile duct cancer, with the highest response rate of the first-generation drugs.
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.
Irreversible covalent binder of the FGFR kinase P-loop cysteine. Connects to FGFR2.
1.Futibatinib slips into a pocket on FGFR2.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA1005. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 4.0 years later, when the FDA's table was read.
| Region | Year | Indication |
|---|---|---|
| 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 · https://www.nice.org.uk/guidance/ta1005 |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Hyperphosphataemia | 85% | 30% |
| Alopecia | 33% | - |
| Dry mouth | 30% | - |
FOENIX-CCA2. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Futibatinib" OR ABSTRACT:"Futibatinib" OR TITLE:"Lytgobi" OR ABSTRACT:"Lytgobi") 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 Futibatinib, not a curated reading list.
Shares FGFR2 fusions and rearrangements, FGFR1, FGFR2 fusion or rearrangement, Infigratinib.
Shares FGFR2 fusions and rearrangements, ctDNA-guided switching among FGFR inhibitors, FGFR2, Intrahepatic cholangiocarcinoma.
Shares ctDNA-guided switching among FGFR inhibitors, FGFR2, Intrahepatic cholangiocarcinoma, Biliary tract cancer (cholangiocarcinoma).
Shares FOENIX-CCA2, FGFR2, Biliary tract cancer (cholangiocarcinoma), Small-molecule kinase inhibitors.
Shares ctDNA-guided switching among FGFR inhibitors, FGFR2, Intrahepatic cholangiocarcinoma, Biliary tract cancer (cholangiocarcinoma).
Shares ctDNA-guided switching among FGFR inhibitors, Intrahepatic cholangiocarcinoma, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma).
Shares FGFR1, FGF / FGFR signalling, Proteoglycans in cancer, FGFR2.
Shares Intrahepatic cholangiocarcinoma, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer.