Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions over exon 21 (L858R) substitution variants. This indication is based on the randomized, open-label, active-controlled trial FLAURA2 where the treatment arm with chemotherapy was investigator's choice of cisplatin (75 mg/m^2) or carboplatin (AUC).

This is written in the approval document as:

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.

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 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