Is Tebentafusp approved by the US FDA?

Drugs@FDA lists 1 application product line for Tebentafusp, including KIMMTRAK (Prescription).

Is Tebentafusp authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tebentafusp: Kimmtrak.

Active substance

Tebentafusp

US FDA 1
EMA 1
Health Canada 1

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

Product	Strength	Form · route	Applicant	Status	First approved
KIMMTRAK	100MCG/0.5ML	injectable · injection	IMMUNOCORE LTD	Prescription	25 Jan 2022

EMA European Union — centrally authorised medicines

Kimmtrak Immunocore Ireland Limited · Authorised · authorised 1 Apr 2022 · ATC L01XX75

Therapeutic indication (EMA)

Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KIMMTRAK	02527588	100 MCG / 0.5 ML	SOLUTION · INTRAVENOUS	IMMUNOCORE IRELAND LIMITED

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.