When will tremelimumab be available on the market?

Tremelimumab is an innovative immune checkpoint inhibitor developed by AstraZeneca. It works by targeting CTLA-4 protein, thereby enhancing the anti-tumor activity of T cells. The drug was first officially approved by the U.S. Food and Drug Administration (FDA) in October 2022 and is used in combination with durvalumab to treat patients with unresectable or advanced hepatocellular carcinoma (uHCC). This approval marks an important breakthrough for CTLA-4 targeted drugs in the field of liver cancer immunotherapy, because before this, systemic treatment of liver cancer mainly relied on targeted drugs, and the options for immune combination therapy were relatively limited.

After FDA approval, temsitumumab quickly received further approval from the European Medicines Agency (EMA). In December 2022, the EMA's Committee for Human Medicinal Products (CHMP) recommended approval of its combination with durvalumab for the same indication, which means that the European market has officially opened the clinical use path for tisimumab. However, there is currently no official marketing information for temsitumumab in China, and the domestic drug regulatory authorities have not yet released relevant review progress. This means that temsitumumab is still in the early stages of introduction in China, has not yet entered the medical insurance catalog, and has not yet formed a legal purchase channel.

The mechanism of temsitumumab is based on reactivation of the immune system. CTLA-4 is a negative regulatory protein on the surface of T cells. It limits the activation of T cells to prevent the immune system from overreacting. Tumor cells often activate this pathway to evade immune system attack. Texitumumab relieves this immune suppression by inhibiting CTLA-4, allowing the body to re-recognize and eliminate cancer cells. Currently, the immune combination therapy of temsitumumab combined with durvalumab has been included in multiple international guidelines to improve the survival prognosis of patients with advanced hepatocellular carcinoma.

Reference: https://www.drugs.com/mtm/tremelimumab.html