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 July 2024. Accessed August 22, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Cisplatin, Osimertinib
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Carboplatin, Osimertinib
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Cisplatin, Osimertinib
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Carboplatin, Osimertinib