Overview of global marketing status of tucatinib/tucatinib

Tucatinib/Tucatinib, a kinase inhibitor anti-cancer drug, has been approved by the U.S. Food and Drug Administration (FDA) since April 2020 and has been launched on the U.S. market. Its combination with trastuzumab and capecitabine offers new hope for patients with unresectable or metastatic HER-2-positive breast cancer (MBC). The drug was developed by Seattle Genetics and sold under the trade name Tukysa. Just four months later, Australia also welcomed the drug's launch.

The mechanism of action of Tucatinib is to inhibit the growth and division of breast cancer cells by binding toHER-2 protein and blocking its signal transduction. When used in combination with other drugs, it can significantly slow the progression of HER2+ breast and colorectal cancer and help patients live longer. But to be clear, this treatment option is not usually intended to be curative.

With widespread recognition of its efficacy,In February 2021, the European Union also approved the medical use of tucatinib. The European Medicines Agency has assessed that for a group of patients with limited treatment options, the use of tucatinib can significantly improve survival rates. At the same time, its reported side effects are within a controllable range, and most of them are related to intestinal reactions. Therefore, the EU believes that the benefits of tucatinib clearly outweigh its potential risks and authorizes its use. In January 2023, the FDA further expanded the use of tucatinib and approved its use in combination with trastuzumab for the treatment of unresectable or metastatic colorectal cancer (CRC).

However, it is worth noting that although tucatinib has been approved and marketed in many countries around the world, as of 2024, it has not yet been approved for marketing in China.