Which country is tucatinib/tucatinib available on the market?

Tucatinib/Tucatinib is an anti-cancer drug that is a kinase inhibitor. In April 2020, it was approved by the U.S. Food and Drug Administration (FDA) for marketing. It can be used together with trastuzumab and capecitabine to treat inoperable diseases. Resected or metastatic HER-2-positive breast cancer (MBC), developed by Seattle Genetics and sold under the trade name Tukysa. In the same yearit was launched in Australia in August.

The EU approved it for medical use in February 2021. The European Medicines Agency noted that evidence showed improved survival with tucatinib in a group of patients who had few other options. Reported side effects were considered manageable and mostly related to effects on the intestines. Therefore, the benefits of tucatinib outweigh its risks and it can be authorized for use. In January 2023, the FDA approved that this drug can also be used in combination with trastuzumab to treat unresectable or metastatic colorectal cancer (CRC). But as of 2024, tucatinib has not yet been approved for marketing in China.

Tucatinib targets the HER-2 protein, but it binds to the protein and shuts down its signaling ability, preventing breast cancer cells from continuing to grow and divide. The combination of tucatinib and other drugs can slow down the progression of HER2+ breast cancer and colorectal cancer and help patients live longer, but it is usually not intended to be cured. Common side effects include diarrhea, palmar-plantar red blood cell paresthesias (burning or tingling discomfort in the hands and feet), nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash. Tucatinib may cause harm to a developing fetus or infant.