AstraZeneca announces first approval of FASLODEX™ (fulvestrant) in Japan

AstraZeneca today announced that FASLODEX™ (fulvestrant) 500mg, an oestrogen receptor antagonist, which binds, blocks and degrades the oestrogen receptor, has received regulatory approval in Japan, for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer which has recurred or progressed following prior endocrine therapy.

Based on the results of the Phase III CONFIRM study (COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer), approval for FASLODEX 500mg was granted in Europe in March 2010 and the US in September 2010. FASLODEX is approved in 72 countries worldwide and the recently launched FASLODEX 500mg dose is now approved in 54 countries.

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.”

In Japan, it is estimated that annually 10,000 women with metastatic breast cancer will have their cancer recurring or progressing post endocrine therapy. AstraZeneca plans to launch FASLODEX 500mg in Japan by the end of 2011.