Imfinzi FDA Approval History
Last updated by Judith Stewart, BPharm on March 29, 2025.
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, Bladder 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, endometrial cancer, and bladder cancer.
- Imfinzi is 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.
- as a single agent, for the treatment of adult patients with unresectable, Stage III 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 NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
- as a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
- 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).
- in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent Imfinzi as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer (MIBC). - 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:
- in combination with chemotherapy in patients with resectable, Stage II/III NSCLC [neoadjuvant /adjuvant]) include anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.
- as a single agent in patients with unresectable, Stage III NSCLC include cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash.
- in combination with tremelimumab-actl and platinum-based chemotherapy in patients with metastatic NSCLC include nausea, fatigue, musculoskeletal pain, decreased appetite, rash, and diarrhea.
- as a single agent in patients with limited-stage SCLC include pneumonitis or radiation pneumonitis, and fatigue.
- in combination with platinum-based chemotherapy in patients with extensive-stage SCLC include nausea, fatigue/asthenia, and alopecia.
- in combination with gemcitabine and cisplatin in patients with BTC include fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and pyrexia.
- in combination with tremelimumab-actl in patients with uHCC include rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain.
- in combination with carboplatin and paclitaxel, followed by Imfinzi as a single agent in patients with endometrial cancer 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, and increased alkaline phosphatase.
- in combination with gemcitabine and cisplatin, followed by Imfinzi as a single agent in patients with MIBC include decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphate, rash, pyrexia, diarrhea, vomiting and abdominal pain.
Development timeline for Imfinzi
Further information
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