APPROVALS

Cambridge, UK-based pharmaceutical company AstraZeneca has announced that its Imjudo treatment for adults with unresectable liver cancer has gained FDA approval. The treatment is to be used alongside Imfinzi, and showed promising results in its phase 3 trial.

Patients treated with Imjudo, in combination with Imfinzi, saw a 22% reduction in the risk of death when compared with those treated with sorafenib, a commonly used oncology drug. The trial showed that 31% of patients treated with the Imjudo-Imfinzi combination were alive after three years, whereas only 20% of those treated with sorafenib were still alive after the same period of time.

The combination Imjudo-Imfinzi treatment includes taking one 300 milligram dose of Imjudo, an anti-CTLA-4 antibody, along with a 1,500 milligram dose of Imfinzi, an anti-PD-L1 antibody, then a dose of Imfinzi every four weeks. Both CTLA-4 and PD-L1 are proteins that slow the body’s immune response, binding to certain other proteins and stopping T cells from killing other cells, such as cancer cells. By stopping CTLA-4 and PD-L1 from binding to these other proteins, the T cells are more able to kill the cancer cells.

Dave Frederickson, Executive Vice President of the Oncology Business Unit, commented: “With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the US now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 inhibition in a unique combination with a PD-L1 inhibitor to enhance the immune response against their cancer.”