Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to durvalumab in combination with tremelimumab-actl and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic aberrations. This indication is based on POSEIDON (NCT03164616), a randomized, open-label, and multicenter study where patients received one of the following chemotherapy regimes: pemetrexed in combination with carboplatin or cisplatin for patients with non-squamous NSCLC, gemcitabine with cisplatin or carboplatin for patients with squamous NSCLC, and nab-paclitaxel with carboplatin for either non-squamous or squamous NSCLC.

This is written in the approval document as:

IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic aberrations.

Citation

AstraZeneca UK Limited. Imfinzi (durvalumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s043lbledt.pdf. Revised August 2024. Accessed October 30, 2024.

View API

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, Pemetrexed, Tremelimumab
Sensitivity (+) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Durvalumab, Pemetrexed, Tremelimumab
Sensitivity (+) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Durvalumab, Gemcitabine, Tremelimumab
Sensitivity (+) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Durvalumab, Gemcitabine, Tremelimumab
Sensitivity (+) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Durvalumab, Nab-paclitaxel, Tremelimumab