AstraZeneca announced that it has received European marketing approval for its new breast cancer drug Faslodex (fulvestrant). 'Faslodex' is indicated for the treatment of advanced breast cancer in post-menopausal women whose cancer has progressed on previous anti-oestrogen treatments such as tamoxifen. This is the first new type of treatment for hormone receptor positive advanced breast cancer to be approved in the European Union since 1995.
In November 2003, AstraZeneca announced that it had received a positive opinion on EU marketing approval for 'Faslodex' from the Committee for Proprietary Medicinal Products (CPMP), scientific advisory body to the European Commission. This was the first time AstraZeneca had submitted a Marketing Authorisation Application (MAA) via the European Centralised Procedure, which now results in a single license for 'Faslodex' throughout the EU, Norway and Iceland, and additional countries when the number of EU member states expands in May 2004. Following this formal EU approval, AstraZeneca expects first launches of 'Faslodex' in Europe in the second quarter, 2004.
'Faslodex' is a novel therapy, with a unique mode of action. It is an oestrogen receptor antagonist with no agonist effects, which binds, blocks and degrades the oestrogen receptor in breast cancer cells. This mode of action is different to aromatase inhibitors that work by reducing the amount of oestrogen in a woman's body. 'Faslodex' is also different to tamoxifen, which blocks the oestrogen receptor, but has some oestrogenic actions that can be associated with a number of unwanted side effects.
The European submission for 'Faslodex' was based on data from two pivotal phase III trials, which compared its efficacy and tolerability to that of 'Arimidex' (anastrozole) in the treatment of hormone sensitive advanced breast cancer in postmenopausal women who had previously been treated with prior endocrine therapy.
'Faslodex' was first launched in the USA in May 2002, and subsequently in Brazil in July 2003. During 2003, 'Faslodex' annual sales in the US reached $77 million. The endocrine breast cancer market in Europe is currently worth over $300 million.