Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized sotorasib as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with the KRAS p.G12C variant and who have progressed after at least one prior line of systemic therapy.

This is written in the approval document as:

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.

Citation

Amgen Europe BV. Lumykras (sotorasib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lumykras-epar-product-information_en.pdf. Revised February 2024. Accessed March 19, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	KRAS p.G12C	Non-Small Cell Lung Cancer	Sotorasib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2022-01-06	European Medicines Agency	Indication received approval from the European Commission.