# KRAS

8 EU-approved indications of 4 drugs need a KRAS result, in 2 tumour types, most of them in colorectal cancer and non-small cell lung cancer.

## Approved indications by tumour

### Non-small cell lung cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Adagrasib](https://oncolabels.com/drugs/adagrasib) (Krazati) | KRAS G12C | Monotherapy | 2nd line, advanced | Disease progression after at least one prior systemic therapy |
| [Sotorasib](https://oncolabels.com/drugs/sotorasib) (Lumykras) | KRAS G12C | Monotherapy | 2nd line, advanced | After at least one prior line of systemic therapy |

### Colorectal cancer

| 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 | - |

## Label wording

- **Adagrasib** (Krazati), Non-small cell lung cancer, 2nd line, advanced: “KRAZATI as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/krazati-epar-product-information_en.pdf)
- **Sotorasib** (Lumykras), Non-small cell lung cancer, 2nd line, advanced: “LUMYKRAS as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and who have progressed after at least one prior line of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lumykras-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)
- **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)

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/kras