Regulatory approval

Published by the Food and Drug Administration. Approved

IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors >= 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

This is written in the approval document.

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Durvalumab, Paclitaxel
FDA (2) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Durvalumab, Gemcitabine
FDA (2) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Durvalumab, Pemetrexed
FDA (2) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Durvalumab, Pemetrexed

Contributions

Date Contributor Description
2025-01-10 Van Allen lab Additional FDA approvals for initial version
2024-08-15 Food and Drug Administration Indication received traditional approval.