Imfinzi FDA Approval History
Last updated by Judith Stewart, BPharm on June 20, 2023.
FDA Approved: Yes (First approved May 1, 2017)
Brand name: Imfinzi
Generic name: durvalumab
Dosage form: Injection
Company: AstraZeneca
Treatment for: Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Biliary Tract Tumor, Hepatocellular Carcinoma
Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody used for the treatment of non-small cell lung cancer, small cell lung cancer, biliary tract cancer, and hepatocellular carcinoma.
- Imfinzi is indicated:
- for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
- 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 tumor aberrations.
- in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
- in combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
- in combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). - Imfinzi contains durvalumab which is a programmed death-ligand 1 (PD-L1) blocking antibody. PD-L1 is an immune checkpoint ligand that can be expressed on both tumor cells and tumor-associated immune cells in the tumor microenvironment. When PD-L1 binds to PD-1 on T-cells, it stops the T-cells from killing the tumor cells that contain PD-L1. By blocking the interaction between PD-L1 and PD-1, durvalumab works to activate the T-cells which then kill the tumor cells.
- Imfinzi is an injection administered via intravenous infusion over 60 minutes.
- Warnings and precautions associated with Imfinzi include immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic HSCT; and embryo-fetal toxicity.
- Common adverse reactions as a single agent include cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash.
Common adverse reactions in combination with platinum-based chemotherapy include nausea, fatigue/asthenia, and alopecia.
Common adverse reactions in combination with gemcitabine and cisplatin include fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and pyrexia.
Common adverse reactions in combination with tremelimumab-actl include rash, diarrhea, fatigue, pruritis, musculoskeletal pain, and abdominal pain.
Common adverse reactions in combination with tremelimumab-actl and platinum-based chemotherapy include nausea, fatigue, musculoskeletal pain, decreased appetite, rash, and diarrhea.
Development timeline for Imfinzi
Further information
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