# Ipilimumab

Ipilimumab (Yervoy, Bristol-Myers Squibb Pharma EEIG) has 9 EU-approved indications in 7 tumour types. 3 need a biomarker result: MMR/MSI (2) and PD-L1 (1).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| No sensitising EGFR mutation or ALK translocation | + nivolumab and 2 cycles of platinum-based chemotherapy | 1st line, metastatic | - |

### Mesothelioma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + nivolumab | 1st line, advanced | Pleural mesothelioma only |

### Colorectal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Mismatch repair deficient or microsatellite instability-high | + nivolumab | 1st line, advanced | - |
| Mismatch repair deficient or microsatellite instability-high | + nivolumab | 2nd line, metastatic | After prior fluoropyrimidine-based combination chemotherapy |

### Oesophageal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Tumour cell PD-L1 expression ≥ 1% | + nivolumab | 1st line, advanced | Squamous cell carcinoma only |

### Hepatocellular carcinoma

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

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + nivolumab | 1st line, advanced | Intermediate/poor-risk |

### Melanoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + nivolumab | Advanced | - |
| None | Monotherapy | Advanced | - |

## Products

### Yervoy

- Company: Bristol-Myers Squibb Pharma EEIG
- Target: CTLA-4 immune checkpoint inhibitor
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX04
- EU approval: 13 Jul 2011
- Label revised: 24 Jun 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/yervoy-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/yervoy

Mechanism (SmPC section 5.1): Ipilimumab blocks CTLA-4-induced inhibitory signals, increasing reactive T-effector cells and reducing regulatory T-cell function to drive an immune attack against tumour cells.

## Label wording

- **Ipilimumab** (Yervoy), Melanoma, advanced: “YERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Melanoma, advanced: “YERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Renal cell carcinoma, 1st line, advanced: “YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Non-small cell lung cancer, 1st line, metastatic: “YERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Mesothelioma, 1st line, advanced: “YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Colorectal cancer, 1st line, advanced: “YERVOY in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings:
- first-line treatment of unresectable or metastatic colorectal cancer;” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Colorectal cancer, 2nd line, metastatic: “YERVOY in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings:
- first-line treatment of unresectable or metastatic colorectal cancer;
- treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Oesophageal cancer, 1st line, advanced: “YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Hepatocellular carcinoma, 1st line, advanced: “YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-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/ipilimumab