Regulatory approval

Published by the European Medicines Agency.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	KRAS p.G12C	Non-Small Cell Lung Cancer	Sotorasib