[Newsmp] The Ministry of Food and Drug Safety of South Korea (MFDS, Minister Oh Yoo-kyung) said Thursday that it had approved two doses (50mg, 150mg) of the new breast cancer drug ‘Tukysa (ingredient: tucatinib)’ developed by MSD Korea.
Tukysa is given in combination with capecitabine and trastuzumab and is used after at least 2 other treatments for HER2-positive cancer have already been treated.
Tucatinib is a tyrosine kinase inhibitor (TKI) that selectively and potently inhibits the HER2 receptor that is overexpressed in cancer cells. It blocks the HER2 pathway signaling, which inhibits tumor cell survival, proliferation, and metastasis, and induces tumor cell death.
"We expect Tukysa to provide a new treatment opportunity for HER2-positive patients who have not responded well to other treatments," MFDS said. "We will continue to work hard to ensure that patients have access to the latest and most effective treatments as quickly as possible, based on our expertise in regulatory science."
