IMJUDO tremelimumab

Drug Class

CTLA-4 inhibitor monoclonal antibody

Mechanism

Blocks CTLA-4 interaction with CD80/CD86, enhancing T-cell activation, proliferation, and anti-tumor immune response.

Approved Indication

FDA-approved in combination with durvalumab for the treatment of adult patients with unresectable hepatocellular carcinoma (uHC).

What This Means For Patients

IMJUDO is an immunotherapy agent targeting CTLA-4. Approved by the FDA and EMA for unresectable liver cancer when combined with durvalumab, it is accessible for clinical use in Hainan.

Regulatory Approvals

• FDA — approved (2022) — label
• EMA — approved (2023) — source

Pivotal Clinical Evidence

• HIMALAYA — Abou-Alfa et al., NEJM Evidence 2022 (NCT03298451) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761298s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/imjudo