Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized tremelimumab in combination with durvalumab 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:

IMJUDO 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.

Citation

AstraZeneca AB. Imjudo (tremelimumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/imjudo-epar-product-information_en.pdf. Revised March 2024. Accessed March 13, 2024.

Therapeutic response

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

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Durvalumab, Tremelimumab