# MMR/MSI 14 EU-approved indications of 6 drugs need a MMR/MSI result, in 5 tumour types, most of them in colorectal cancer, endometrial cancer and gastric and GEJ adenocarcinoma. ## Approved indications by tumour ### Small intestine cancer | Drug | Biomarker requirement | Regimen | Setting | Conditions | |---|---|---|---|---| | [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | MMR/MSI deficient | Monotherapy | 2nd line, advanced | Disease progression on or following at least one prior therapy | ### Colorectal cancer | 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 | ### Gastric and GEJ adenocarcinoma | Drug | Biomarker requirement | Regimen | Setting | Conditions | |---|---|---|---|---| | [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | MMR/MSI deficient | Monotherapy | 2nd line, advanced | Disease progression on or following at least one prior therapy | ### Biliary tract cancer | Drug | Biomarker requirement | Regimen | Setting | Conditions | |---|---|---|---|---| | [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | MMR/MSI deficient | Monotherapy | 2nd line, advanced | Disease progression on or following at least one prior therapy | ### Endometrial cancer | Drug | Biomarker requirement | Regimen | Setting | Conditions | |---|---|---|---|---| | [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | Mismatch repair proficient (pMMR) | + olaparib | Maintenance, advanced | After first-line durvalumab + carboplatin and paclitaxel without progression; Candidates for systemic therapy | | [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | Mismatch repair deficient (dMMR) | Monotherapy | Maintenance, advanced | After first-line durvalumab + carboplatin and paclitaxel without progression; Candidates for systemic therapy | | [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | Mismatch repair proficient | + durvalumab | Maintenance, advanced | After first-line treatment with durvalumab in combination with carboplatin and paclitaxel without progression | | [Dostarlimab](https://oncolabels.com/drugs/dostarlimab) (Jemperli) | MMR/MSI deficient | Monotherapy | 2nd line, advanced | Progressed on or following prior treatment with a platinum-containing regimen | | [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | MMR/MSI deficient | Monotherapy | Advanced | Disease progression on or following prior treatment with a platinum-containing therapy in any setting; Not candidates for curative surgery or radiation | ## 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) - **Pembrolizumab** (Keytruda), Endometrial cancer, advanced: “advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation;” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf) - **Pembrolizumab** (Keytruda), Gastric and GEJ adenocarcinoma, 2nd line, advanced: “unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf) - **Pembrolizumab** (Keytruda), Small intestine cancer, 2nd line, advanced: “unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf) - **Pembrolizumab** (Keytruda), Biliary tract cancer, 2nd line, advanced: “unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior 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) - **Dostarlimab** (Jemperli), Endometrial cancer, 2nd line, advanced: “JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum-containing regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/jemperli-epar-product-information_en.pdf) - **Durvalumab** (Imfinzi), Endometrial cancer, maintenance, advanced: “IMFINZI as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf) - **Durvalumab** (Imfinzi), Endometrial cancer, maintenance, advanced: “IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf) - **Olaparib** (Lynparza), Endometrial cancer, maintenance, advanced: “Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-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/biomarkers/mmr-msi