Regulatory approval

Published by the European Medicines Agency. Approved

Aumseqa as monotherapy is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or EGFR exon 21 (L858R) substitution mutations.

This is written in the approval document.

Citation

SFL Pharmaceuticals Deutschland GmbH. Aumseqa (aumolertinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/aumseqa-epar-product-information_en.pdf. Revised February 2026. Accessed August 2, 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Aumolertinib
EMA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Aumolertinib