Talimogene laherparepvec

Talimogene laherparepvec (Imlygic, Amgen Europe B.V.) has 1 EU-approved indication in 1 tumour type.
Approved indications of Talimogene laherparepvec
Biomarker requirementRegimenSettingConditions
Melanoma1
None
Monotherapy
Any line
advanced
Unresectable; Stage IIIB, IIIC and IVM1a; no bone, brain, lung or other visceral disease
Full text of section 4.1 (therapeutic indications)

Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease (see sections 4.4 and 5.1).

Label history

18 changes to the Imlygic label since 2017, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes