Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that EGFR activating variants status confers therapeutic sensitivity to Osimertinib in patients with Non-Small Cell Lung Cancer.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.