Regulatory approval

Published by the European Medicines Agency. Approved

TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution 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 Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Cisplatin, Osimertinib
EMA (1)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Carboplatin, Osimertinib
EMA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Cisplatin, Osimertinib
EMA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Carboplatin, Osimertinib