Aumseqa (aumolertinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 2
Aumseqa as monotherapy is indicated for the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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
EMA (1) EGFR p.T790M Non-Small Cell Lung Cancer Aumolertinib