Tebentafusp

Tebentafusp (Kimmtrak, Immunocore Ireland Limited) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: HLA-A*02:01 (1).
Approved indications of Tebentafusp
Biomarker requirementRegimenSettingConditions
Uveal melanoma1
HLA-A*02:01-positive
Monotherapy
Any line
advanced
None
Full text of section 4.1 (therapeutic indications)

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.

Label history

5 changes to the Kimmtrak label since 2024, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes