# Sotorasib

Sotorasib (Lumykras, Amgen Europe B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: KRAS (1).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| KRAS G12C | Monotherapy | 2nd line, advanced | After at least one prior line of systemic therapy |

## Products

### Lumykras

- Company: Amgen Europe B.V.
- Target: KRAS G12C inhibitor
- Class: Other antineoplastic agents
- ATC: L01XX73
- EU approval: 6 Jan 2022
- Label revised: 8 Oct 2026
- Status: conditional approval
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/lumykras-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/lumykras-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/lumykras

Mechanism (SmPC section 5.1): Sotorasib covalently and irreversibly binds to KRAS G12C, blocking downstream tumour cell signalling and survival, inhibiting growth, and promoting apoptosis.

## Label wording

- **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)

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/sotorasib