When was lapatinib officially launched?

Lapatinib(Lapatinib) is a dual-targeted oral drug developed by the pharmaceutical company GlaxoSmithKline (GSK). It is mainly used for the targeted treatment of HER2-positive breast cancer. The drug was first approved for marketing globally in 2007, when the US FDA approved lapatinib combined with capecitabine for the treatment of patients with HER2-positive advanced breast cancer whose disease has progressed after treatment with trastuzumab. This breakthrough approval makes lapatinib another important HER2-targeted drug after trastuzumab.

In China, the registration and approval process for lapatinib is relatively late. According to information released by the National Food and Drug Administration (NMPA, formerly CFDA), lapatinib officially obtained China's marketing authorization in 2013 and entered the domestic market under the trade name "Talisa". At the beginning of its launch, lapatinib was used in combination with other chemotherapy drugs to treat HER2-positive breast cancer. It was also used to control brain metastases in certain clinical programs. Its unique molecular structure gave it an advantage in penetrating the blood-brain barrier compared with some antibody drugs.

The launch of lapatinib in China not only enriches the treatment options for HER2-positive breast cancer, but also promotes the popularization of oral targeted drugs in breast cancer treatment systems. Especially for patients who are not suitable for long-term intravenous administration or who have developed resistance to first-line targeted drugs, lapatinib provides a new treatment idea. Since its launch, although the drug has not been included in the national medical insurance list, it still occupies a place in the oncology treatment guidelines.

At present, although new generations of HER2-targeted drugs such as pyrotinib and emtrastuzumab are constantly emerging around the world, lapatinib still maintains important clinical value in some specific groups, especially when resources are limited or other treatments have failed.

Reference materials:https://medlineplus.gov/druginfo/meds/a607055.html