CHMP recommends Imjudo + Imfinzi combination to treat liver cancer- AstraZeneca
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Imjudo, intended for the treatment of hepatocellular carcinoma. The applicant for this medicinal product is AstraZeneca AB.
Imjudo will be available as a 20 mg/ml concentrate for solution for infusion. The active substance of Imjudo is tremelimumab, a monoclonal antibody (ATC code: L01FX20). It binds to CTLA-4, which is primarily expressed on the surface of activated T lymphocytes, and thus enhances T-cell activation and proliferation, resulting in increased T-cell diversity and enhanced anti-tumour activity.
The benefit of Imjudo in combination with durvalumab is a significant improvement in overall survival compared with the standard of care, sorafenib, as observed in a randomised, open-label, multicentre Phase III study in patients with unresectable hepatocellular carcinoma. The most common side effects are rash, pruritus, diarrhoea, abdominal pain, AST increased, pyrexia, hypothyroidism, cough/productive cough, oedema peripheral and lipase increased.
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