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Imjudo
Published
Product name
Imjudo
Active ingredient
Tremelimumab
Submission type
New Biological Entity
Decision
Approved.
Decision date
Registration date
What this medicine was approved for
Imjudo (tremelimumab) was approved for the following therapeutic use:
Hepatocellular Carcinoma (HCC)
Imjudo in combination with durvalumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior treatment with a PD-1/PD-L1 inhibitor.
How this medicine works
Cytotoxic T-lymphocyte associated protein (CTLA)-4 is primarily expressed on the surface of T lymphocytes. Interaction of CTLA-4 with its ligands, cluster of differentiation (CD)80 and CD86, limits effector T-lymphocyte activation, through a number of potential mechanisms, but primarily by limiting co-stimulatory signalling through CD28.
Tremelimumab is a selective, fully human immunoglobulin G (IgG)2 antibody that blocks CTLA 4 interaction with CD80 and CD86, thus enhancing T-lymphocyte activation and proliferation, resulting in increased T-lymphocyte diversity and enhanced antitumour immune activity. In syngeneic mouse tumour models, blocking CTLA-4 activity resulted in decreased tumour growth and increased proliferation of T-lymphocytes in tumours. The combination of durvalumab, a programmed death-ligand (PD-L)1 inhibitor, and tremelimumab functions to enhance anti-tumour T-lymphocyte activation and functions at multiple stages of the immune response, maximizing anti-tumour immunity.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Imjudo was considered favourable for the therapeutic use approved.
Sponsor