Imfinzi (durvalumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

AstraZeneca UK Limited. Imfinzi (durvalumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761069s033lbl.pdf. Revised November 2022. Accessed October 6, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 5

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Durvalumab, Pemetrexed, Tremelimumab
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Durvalumab, Pemetrexed, Tremelimumab
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Durvalumab, Gemcitabine, Tremelimumab
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Durvalumab, Gemcitabine, Tremelimumab
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Durvalumab, Nab-paclitaxel, Tremelimumab