Imfinzi (durvalumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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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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
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). 1
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. 4

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
FDA (1) dMMR Endometrial Carcinoma Carboplatin, Durvalumab, Paclitaxel
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Durvalumab, Paclitaxel
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Durvalumab, Gemcitabine
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Durvalumab, Pemetrexed
FDA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Durvalumab, Pemetrexed