# Tremelimumab

Tremelimumab (Imjudo, AstraZeneca AB) has 2 EU-approved indications in 2 tumour types.

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| No sensitising EGFR mutations or ALK positive mutations | + durvalumab and platinum-based chemotherapy | 1st line, metastatic | - |

### Hepatocellular carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + durvalumab | 1st line, advanced | - |

## Products

### Imjudo

- Company: AstraZeneca AB
- Target: CTLA-4 inhibitor (antibody)
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX20
- EU approval: 20 Feb 2023
- Label revised: 14 Aug 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/imjudo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/imjudo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/imjudo

Mechanism (SmPC section 5.1): Tremelimumab is a monoclonal antibody that blocks CTLA-4 interaction with CD80 and CD86, enhancing T-cell activation and anti-tumour activity.

## Label wording

- **Tremelimumab** (Imjudo), Hepatocellular carcinoma, 1st line, advanced: “IMJUDO in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imjudo-epar-product-information_en.pdf)
- **Tremelimumab** (Imjudo), Non-small cell lung cancer, 1st line, metastatic: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imjudo-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/tremelimumab