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.

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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
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