Regulatory approval

Published by the European Medicines Agency. Withdrawn

Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

This is written in the approval document.

Citation

AstraZeneca AB. Tremelimumab AstraZeneca (tremelimumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tremelimumab-astrazeneca-epar-product-information_en.pdf. Revised September 2023. Accessed March 25, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies

Contributions

Date	Contributor	Description
2025-09-05	Van Allen lab	On 2023-11-06, the European Commission withdrew the market authorization for Tremelimumab AstraZeneca (tremelimumab) in the European Union at the request of the marketing authorization holder, AstraZeneca AB, due to their decision to permanently discontinue the marketing of the product for commercial reasons.
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2023-02-20	European Medicines Agency	Indication received approval from the European Commission.