Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that EGFR Exon 19 (Deletion) status confers therapeutic sensitivity to Osimertinib in patients with Non-Small Cell Lung Cancer.

The European Medicines Agency (EMA) has authorized 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.

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

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.

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
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.