Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized durvalumab in combination with tremelimumab and platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) and no sensitizing EGFR mutations or ALK positive mutations. This indication is POSEIDON (NCT03164616), a randomized, multicenter, active-controlled, and open-label study where the specific chemotherapy regime used was based on the histology of the patient's NSCLC.

This is written in the approval document as:

IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.

Citation

AstraZeneca AB. Imfinzi (durvalumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf. Revised July 2025. Accessed August 29, 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Durvalumab, Tremelimumab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2023-01-30	European Medicines Agency	Indication received approval from the European Commission.