Regulatory approval

Published by the European Medicines Agency. Approved

TAGRISSO as a monotherapy is indicated for the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.

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 Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Osimertinib
EMA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Osimertinib

Contributions

Date	Contributor	Description
2025-09-05	Van Allen lab	On 2025-01-09, the EMA published an EPAR - Assessment report - Variation for Tagrisso (osimertinib) that added an extension indication to osimertinib for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
2016-02-01	European Medicines Agency	Indication received approval from the European Commission.