Astrazeneca announces EU marketing approval for Faslodex(TM)

Alderley Park, UK, 12 March 2004: AstraZeneca announced today that it has received European marketing approval for its new breast cancer drug FASLODEXTM (fulvestrant). The novel drug is indicated for the treatment of postmenopausal women with receptor-positive locally advanced or metastatic breast cancer, for disease relapse or progression on or after therapy with an anti-oestrogen such as tamoxifen. 'Faslodex' has been launched in the USA since May 2002, and more recently in Brazil in July 2003.

Breast cancer affects 1 in 9 women at some point in their lives and although many tumours are detected early and treated successfully, a large number of women still go on to be diagnosed with advanced breast cancer. The goal of treatment for these women is to achieve an effective disease response and to enable the patient to maintain good quality of life for as long as is feasibly possible. Hormonal agents such as aromatase inhibitors and tamoxifen are standard therapy in postmenopausal women with advanced breast cancer, providing an effective and well-tolerated treatment option. However, in time tumour cells can grow resistant to treatment with these hormonal therapies and as a result there is a need for new agents to which tumours are not resistant. 'Faslodex' is an exciting new type of therapy, which brings new choices for women with advanced disease, extending the sequence of 'patient-friendly' hormonal therapies that can be used to control the disease.

'Faslodex' is a novel therapy, the first of a new type, with a unique mode of action. The new drug is an oestrogen receptor antagonist with no agonist effects that binds, blocks and degrades the oestrogen receptor in breast cancer cells. This mode of action is different to the aromatase inhibitors that work by reducing the amount of oestrogen in a woman's body. It is also different to tamoxifen, which blocks the oestrogen receptor but which also has some oestrogenic actions which can be associated w

Contact: Alison Wright
Shire Health International

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