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

Monday, 26 September 2011

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.


About FASLODEX 500mg

The main goal of metastatic breast cancer treatment is to delay disease progression, whilst maintaining quality of life. FASLODEX 500mg has a different mechanism of action from other endocrine (hormonal) therapies: in addition to blocking the action of oestrogen at its receptor, it also disrupts oestrogen signalling, leading to down-regulation of the oestrogen receptors in the tumour. 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.

About AstraZeneca in Japan

As its second largest market globally, Japan is of strategic importance to AstraZeneca. Revenue grew by 4% in 2010 to $2,617 million, with global brands such as CRESTOR and SYMBICORT TURBUHALER contributing to continued growth. AstraZeneca launched NEXIUM (esomeprazole) in Japan this year.

AstraZeneca has steadily built a significant presence in Japan with 3,100 employees, an R&D centre in Osaka and is one of the pharmaceutical leaders in the field of oncology.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit:


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