Regulatory approval

Published by the European Medicines Agency.

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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	EGFR oncogenic variants	Non-Small Cell Lung Cancer	Osimertinib