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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
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

Contributions

Date Contributor Description
2025-08-29 Van Allen lab On 2025-06-18, the EMA published an EPAR - Assessment report - Variation that added an extension indication to durvalumab for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.
2025-03-31 European Medicines Agency Indication received approval from the European Commission.