Futibatinib
Futibatinib is a covalent FGFR inhibitor for FGFR2-fusion bile duct cancer, with the highest response rate of the first-generation drugs.
FOENIX-CCA2 (NEJM 2023): ORR 42%, median PFS 9.0 months, median OS 21.7 months in previously treated FGFR2-rearranged intrahepatic cholangiocarcinoma. Accelerated approval September 2022; EMA 2023. Retains activity against some resistance mutations.
- Route
- Oral
- Schedule
- 20 mg daily continuously
- Monitoring
- Phosphate, eyes
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Taiho Oncology Patient Support
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Notes
- EU-licensed 2023 for FGFR2-rearranged cholangiocarcinoma; UK licence and NICE position not yet researched.
Sources: NICE search: futibatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2022 | Previously treated FGFR2-fusion/rearranged intrahepatic cholangiocarcinoma (accelerated) |
| EU | 2023 | Same |
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductPemigatinib
Shares FGFR2 fusions and rearrangements, ctDNA-guided switching among FGFR inhibitors, FGFR2, Biliary tract cancer (cholangiocarcinoma).
- ProductTinengotinib
Shares FGFR2 fusions and rearrangements, ctDNA-guided switching among FGFR inhibitors, FGFR2, Biliary tract cancer (cholangiocarcinoma).
- TrialFIGHT-202
- TrialFIRST-308
- TermIntrahepatic, perihilar, distal and gallbladder cancer
- ProductErdafitinib
Shares FGFR2, Small-molecule kinase inhibitors.
- PersonTanios Bekaii-Saab
- InstitutionNational Cancer Centre Singapore