Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized osimertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with activating EGFR variants.

This is written in the approval document as:

TAGRISSO as monotherapy is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.

Citation

AstraZeneca AB. Tagrisso (osimertinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf. Revised January 2025. Accessed September 5, 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	EGFR activating variants	Non-Small Cell Lung Cancer	Osimertinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2018-06-07	European Medicines Agency	Indication received approval from the European Commission.