Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized durvalumab as a monotherapy for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors express PD-L1 on >= 1% of tumor cells and whose disease has not progressed following platinum-based chemoradiation therapy.

This is written in the approval document as:

IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on >= 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.

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)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Durvalumab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2018-09-21	European Medicines Agency	Indication received approval from the European Commission.