Regulatory approval

Published by the European Medicines Agency. Approved

IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.

This is written in the approval document.

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, Paclitaxel
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Durvalumab, Gemcitabine
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Durvalumab, Pemetrexed
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Durvalumab, Pemetrexed