Tremelimumab

Tremelimumab (Imjudo, AstraZeneca AB) has 2 EU-approved indications in 2 tumour types.
Approved indications of Tremelimumab
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer1
No sensitising EGFR mutations or ALK positive mutations
+ durvalumab and platinum-based chemotherapy
1L
metastatic
None
Hepatocellular carcinoma1
None
+ durvalumab
1L
advanced
None
Full text of section 4.1 (therapeutic indications)

IMJUDO in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). IMJUDO in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

Label history

8 changes to the Imjudo label since 2023, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes