Imfinzi FDA Approval History
Last updated by Judith Stewart, BPharm on June 17, 2024.
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, Endometrial Cancer
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, hepatocellular carcinoma, and endometrial cancer.
- 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).
- 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). - 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.
- in combination with platinum-based chemotherapy include nausea, fatigue/asthenia, and alopecia.
- in combination with gemcitabine and cisplatin include fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and pyrexia.
- in combination with tremelimumab-actl include rash, diarrhea, fatigue, pruritis, musculoskeletal pain, and abdominal pain.
- in combination with tremelimumab-actl and platinum-based chemotherapy include nausea, fatigue, musculoskeletal pain, decreased appetite, rash, and diarrhea.
- in combination with carboplatin and paclitaxel, followed by Imfinzi as a single agent, include peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation, rash, decreased magnesium, increased ALT, increased AST, diarrhea, vomiting, cough, decreased potassium, dyspnea, headache, increased alkaline phosphatase, and decreased appetite.
Development timeline for Imfinzi
Further information
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