Regulatory approval

Published by the European Medicines Agency.

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

IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.

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 August 2024. Accessed August 24, 2024.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Durvalumab, Tremelimumab