LONDON (dpa-AFX) - AstraZeneca PLC (AZN.L) Monday said it received approval from the US Food and Drug Administration for the combination of Imjudo and Imfinzi to treat adults with unresectable liver cancer.
The approval was based on positive results from the HIMALAYA Phase III trial, which showed that patients treated with Imjudo in combination with Imfinzi experienced a 22% reduction in the risk of death versus Bayer's sorafenib.
Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), the company said. AstraZeneca's Imfinzi (durvalumab) was first approved in the US in 2017 for the treatment of advanced bladder cancer.
Regulatory applications for Imjudo in combination with Imfinzi are currently under review in Europe and Japan among other countries for the treatment of patients with advanced liver cancer.
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