AstraZeneca announced today that their FASLODEX 500mg product received its first regulatory approval in Japan.
FASLODEX 500mg is a breast cancer drug which had already gained regulatory approval in Europe in March, 2010 and in the United States one year ago in September, 2010. Regulatory approval for the products’ roll-out was approved after a Phase III CONFIRM study was completed.
In a company statement, Tony Zook, Executive Vice President of AstraZeneca’s Global Commercial Organisation said, “We are very pleased to bring this important and well established medicine for the first time to doctors and their patients in Japan, our second largest market. The main goal of metastatic breast cancer treatment is to prevent disease progression while maintaining quality of life and FASLODEX 500mg will give women the possibility of more control over their disease.”
According to AstraZeneca, FASLODEX 500mg works by blocking the action of oestrogen at its receptor. Furthermore, it also disrupts oestrogen signaling, leading to down-regulation of the oestrogen receptors in the tumor. The company says that this distinct mechanism of action not only reduces the growth and spread of the cancer but may help to reduce or delay resistance to treatment.
FASLODEX is approved in 72 countries around the world and 500mg doses are approved in 54 countries. AstraZeneca said that they expect FASLODEX 500mg to be launched in Japan by the end of July of this year.