Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized osimertinib for treatment of adult patients with locally advanced or metastatic EGFR p.T790M mutation-positive non-small cell lung cancer.

This is written in the approval document as:

TAGRISSO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

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 p.T790M	Non-Small Cell Lung Cancer	Osimertinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2016-02-01	European Medicines Agency	Indication received approval from the European Commission.