# MMR/MSI in colorectal cancer

6 EU-approved indications in colorectal cancer need a MMR/MSI result: pembrolizumab (1st line, metastatic), pembrolizumab (2nd line, advanced), nivolumab (1st line, advanced), nivolumab (2nd line, metastatic), ipilimumab (1st line, advanced) and ipilimumab (2nd line, metastatic).

## Approved indications

### dMMR / MSI-H

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Ipilimumab](https://oncolabels.com/drugs/ipilimumab) (Yervoy) | Mismatch repair deficient or microsatellite instability-high | + nivolumab | 1st line, advanced | - |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | Mismatch repair deficient or microsatellite instability-high | + ipilimumab | 1st line, advanced | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | MMR/MSI deficient | Monotherapy | 1st line, metastatic | - |
| [Ipilimumab](https://oncolabels.com/drugs/ipilimumab) (Yervoy) | Mismatch repair deficient or microsatellite instability-high | + nivolumab | 2nd line, metastatic | After prior fluoropyrimidine-based combination chemotherapy |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | Mismatch repair deficient or microsatellite instability-high | + ipilimumab | 2nd line, metastatic | After prior fluoropyrimidine-based combination chemotherapy |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | MMR/MSI deficient | Monotherapy | 2nd line, advanced | After previous fluoropyrimidine-based combination therapy |

## Label wording

- **Pembrolizumab** (Keytruda), Colorectal cancer, 1st line, metastatic: “first-line treatment of metastatic colorectal cancer;” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Colorectal cancer, 2nd line, advanced: “treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Colorectal cancer, 1st line, advanced: “first-line treatment of unresectable or metastatic colorectal cancer;” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Colorectal cancer, 2nd line, metastatic: “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/opdivo-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)

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/tumours/colorectal-cancer/mmr-msi