Faslodex granted European marketing approval

AstraZeneca 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 antioestrogen treatments such as tamoxifen. This is the first new type of treatment for hormone receptor positive advanced breast cancer to be approved in the EU since 1995. Following this formal EU approval, AstraZeneca expects first launches of Faslodex in Europe in the second quarter of 2004.

In November 2003, AstraZeneca received a positive opinion on EU marketing approval for Faslodex from the Committee for Proprietary Medicinal Products (CPMP). This was the first time AstraZeneca had submitted a Marketing Authorisation Application 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.

Faslodex 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.

It was first launched in the US in May 2002, and subsequently in Brazil in July last year. During 2003, Faslodex annual sales of Faslodex in the US reached $77m. The endocrine breast cancer market in Europe is currently worth more than $300m.