# Colorectal cancer

The EU has approved 21 indications of 11 drugs in colorectal cancer. 10 of them need a biomarker result: MMR/MSI (6) and BRAF (4). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### BRAF mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Cetuximab](https://oncolabels.com/drugs/cetuximab) (Erbitux) | BRAF V600E | + encorafenib and FOLFOX | 1st line, metastatic | - |
| [Encorafenib](https://oncolabels.com/drugs/encorafenib) (Braftovi) | BRAF V600E | + cetuximab and FOLFOX | 1st line, metastatic | - |
| [Cetuximab](https://oncolabels.com/drugs/cetuximab) (Erbitux) | BRAF V600E | + encorafenib | 2nd line, metastatic | After prior systemic therapy |
| [Encorafenib](https://oncolabels.com/drugs/encorafenib) (Braftovi) | BRAF V600E | + cetuximab | 2nd line, metastatic | After prior systemic therapy |

### 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 |

### RAS negative

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Cetuximab](https://oncolabels.com/drugs/cetuximab) (Erbitux) | RAS wild-type, EGFR-expressing | + FOLFOX | 1st line, metastatic | - |
| [Panitumumab](https://oncolabels.com/drugs/panitumumab) (Vectibix) | Wild-type RAS | + FOLFOX or FOLFIRI | 1st line, metastatic | - |
| [Panitumumab](https://oncolabels.com/drugs/panitumumab) (Vectibix) | Wild-type RAS | + FOLFIRI | 2nd line, metastatic | After first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) |
| [Cetuximab](https://oncolabels.com/drugs/cetuximab) (Erbitux) | RAS wild-type, EGFR-expressing | Monotherapy | 3rd line+, metastatic | Failed oxaliplatin- and irinotecan-based therapy; Intolerant to irinotecan Ambiguous in the label (line of therapy): check the SmPC. |
| [Panitumumab](https://oncolabels.com/drugs/panitumumab) (Vectibix) | Wild-type RAS | Monotherapy | 3rd line+, metastatic | Failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens |
| [Cetuximab](https://oncolabels.com/drugs/cetuximab) (Erbitux) | RAS wild-type, EGFR-expressing | + irinotecan-based chemotherapy | Metastatic | - |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Aflibercept](https://oncolabels.com/drugs/aflibercept) (Zaltrap) | None | + irinotecan/5-fluorouracil/folinic acid (FOLFIRI) | 2nd line, metastatic | After oxaliplatin-containing regimen (resistant to or progressed after) |
| [Ramucirumab](https://oncolabels.com/drugs/ramucirumab) (Cyramza) | None | + FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) | 2nd line, metastatic | After bevacizumab, oxaliplatin and a fluoropyrimidine |
| [Fruquintinib](https://oncolabels.com/drugs/fruquintinib) (Fruzaqla) | None | Monotherapy | 3rd line+, metastatic | After available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and progressed on or intolerant to either trifluridine-tipiracil or regorafenib |
| [Bevacizumab](https://oncolabels.com/drugs/bevacizumab) (Avastin) | None | + fluoropyrimidine-based chemotherapy | Metastatic | - |
| [Regorafenib](https://oncolabels.com/drugs/regorafenib) (Stivarga) | None | Monotherapy | Metastatic | Previously treated with, or are not considered candidates for, available therapies (including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy) |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## 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)
- **Bevacizumab** (Avastin), Colorectal cancer, metastatic: “Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Fruquintinib** (Fruzaqla), Colorectal cancer, 3rd line+, metastatic: “FRUZAQLA as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/fruzaqla-epar-product-information_en.pdf)
- **Encorafenib** (Braftovi), Colorectal cancer, 2nd line, metastatic: “Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, who have received prior systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf)
- **Encorafenib** (Braftovi), Colorectal cancer, 1st line, metastatic: “Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf)
- **Cetuximab** (Erbitux), Colorectal cancer, metastatic: “Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer
• in combination with irinotecan-based chemotherapy,” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf)
- **Cetuximab** (Erbitux), Colorectal cancer, 1st line, metastatic: “Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer
• in combination with irinotecan-based chemotherapy,
• in first-line in combination with FOLFOX,” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf)
- **Cetuximab** (Erbitux), Colorectal cancer, 3rd line+, metastatic: “Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer
• in combination with irinotecan-based chemotherapy,
• in first-line in combination with FOLFOX,
• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf)
- **Cetuximab** (Erbitux), Colorectal cancer, 1st line, metastatic: “• in combination with encorafenib and FOLFOX for the first line treatment.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf)
- **Cetuximab** (Erbitux), Colorectal cancer, 2nd line, metastatic: “• in combination with encorafenib in patients who have received prior systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-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)
- **Regorafenib** (Stivarga), Colorectal cancer, metastatic: “- metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/stivarga-epar-product-information_en.pdf)
- **Ramucirumab** (Cyramza), Colorectal cancer, 2nd line, metastatic: “Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cyramza-epar-product-information_en.pdf)
- **Panitumumab** (Vectibix), Colorectal cancer, 1st line, metastatic: “in first-line in combination with FOLFOX or FOLFIRI.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vectibix-epar-product-information_en.pdf)
- **Panitumumab** (Vectibix), Colorectal cancer, 2nd line, metastatic: “in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vectibix-epar-product-information_en.pdf)
- **Panitumumab** (Vectibix), Colorectal cancer, 3rd line+, metastatic: “as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vectibix-epar-product-information_en.pdf)
- **Aflibercept** (Zaltrap), Colorectal cancer, 2nd line, metastatic: “ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zaltrap-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