Is Futibatinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Futibatinib, including LYTGOBI (Prescription); LYTGOBI (Discontinued).

Is Futibatinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Futibatinib: Lytgobi.

Are there safety signals or safety updates for Futibatinib?

US FDA: 1 entry (latest 2025-10-15).

Active substance

Futibatinib

US FDA 2
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LYTGOBI	4MG	tablet · oral	TAIHO ONCOLOGY	Prescription	30 Sep 2022
LYTGOBI	16MG	tablet · oral	TAIHO ONCOLOGY	Discontinued	30 Sep 2022

EMA European Union — centrally authorised medicines

Lytgobi Taiho Pharma Netherlands B.V. · Authorised · authorised 4 Jul 2023 · ATC L01EN04

Therapeutic indication (EMA)

Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Safety signals and safety-related labeling changes

US FDA 15 Oct 2025 LYTGOBI — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations

All safety entries for futibatinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.