Regulatory approval

Published by the European Medicines Agency. Approved

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

This is written in the approval document.

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