The Russian Ministry of Health has approved the AstraZeneca drug for patients with inoperable hepatocellular cancer. Tremelimumab in combination with durvalumab was approved in the United States for this indication in October 2022.
AstraZeneca has received a registration certificate from the Ministry of Health for the drug Imjudo (INN tremelimumab), Pharmaceutical Bulletin reported with reference to information in the State Register of Medicines (GRLS). The drug is used in combination with durvalumab for the treatment of unresectable hepatocellular cancer (nHCC).
Tremelimumab is a human monoclonal antibody. Suppresses the activity of CTLA-4, promoting the activation of T lymphocytes, initiating an immune response to the tumor and stimulating the death of tumor cells.
The drug is available as a concentrate for the preparation of a solution for infusion of 20 mg/ml. It is contraindicated for children, pregnant and lactating women.
In March, AstraZeneca’s combination of immunotherapies durvalumab and tremelimumab was approved in the European Union (EU) for the treatment of common forms of liver and lung cancer – unresectable hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC). The decisions are based on the results of the phase III studies of HIMALAYA and POSEIDON, which showed a significant increase in survival in these diseases.
In October 2022, tremelimumab in combination with durvalumab was approved by the US Food and Drug Administration (FDA) for the treatment of nHCC. The effectiveness of therapy was assessed in the randomized, open-label, multicenter trial HIMALAYA in patients with confirmed nHCC. During the trial, patients received a single dose of tremelimumab (300 mg) and durvalumab (1500 mg), followed by durvalumab every 4 weeks. The use of this regimen significantly reduced the risk of death compared with sorafenib therapy – by 22%.