OnCo
drugsProductApproved2022🇪🇺🇬🇧🇯🇵

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.

Loading structure…
|
Futibatinib
PubChem
Modality
Small-molecule irreversible kinase inhibitor (FGFR1-4)
Mechanism
Irreversible covalent binder of the FGFR kinase P-loop cysteine.
Brand / code
Lytgobi
Dosing & schedule
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

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.

Not yet researchedSearch NICE
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.

Regulatory

2top

Approvals

RegionYearIndication
US2022Previously treated FGFR2-fusion/rearranged intrahepatic cholangiocarcinoma (accelerated)
EU2023Same

Safety

3top
Toxicity profile
Adverse eventAny gradeGrade 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

top
ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
20 studies8 recruiting15 Phase 26 Phase 3
Search “Futibatinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Futibatinib
intervention: Futibatinib
Open on ClinicalTrials.gov →

Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.

Landmark trials in OnCo

Latest papers

top
Literature trend29 papers in the last 12 months+81% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

7top