Imjudo FDA Approval History
Last updated by Judith Stewart, BPharm on July 11, 2023.
FDA Approved: Yes (First approved October 21, 2022)
Brand name: Imjudo
Generic name: tremelimumab-actl
Dosage form: Injection
Company: AstraZeneca
Treatment for: Hepatocellular Carcinoma, Non-Small Cell Lung Cancer
Imjudo (tremelimumab-actl) is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab (Imfinzi) for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC), and in combination with durvalumab 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) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
- Imjudo contains tremelimumab, a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), which is expressed on the surface of T-lymphocytes. By blocking the activity of CTLA-4, tremelimumab contributes to T-cell activation, priming the immune response to cancer and fostering cancer cell death.
- Imjudo is administered as an intravenous infusion over a period of 60 minutes.
- Warnings and precautions associated with Imjudo include immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, nephritis, and pancreatitis), infusion-related reactions, and embryo-fetal toxicity.
- Common adverse reactions include rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain. Common laboratory abnormalities include increased AST, increased ALT, decreased hemoglobin, decreased sodium, increased bilirubin, increased alkaline phosphatase, and decreased lymphocytes.
Development timeline for Imjudo
Further information
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