FDA Approval - Faslodex

AstraZeneca PLC 26 April 2002 AstraZeneca receives FDA approval for Faslodex- a new type of breast cancer treatment AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for its new breast cancer drug 'Faslodex' for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antioestrogen therapy, (e.g. tamoxifen). The breast cancer market in the USA is currently worth over $1 billion. An estimated 203,500 new cases of invasive breast cancer will be diagnosed in the USA and an estimated 39,600 women will die of breast cancer in 2002. A portion of newly diagnosed breast cancer cases will be initially diagnosed in the advanced or locally advanced stages where cancer has spread to the lymph nodes and/or other parts of the body. Two pivotal Phase III trials showed 'Faslodex' to be at least as effective as the aromatase inhibitor 'Arimidex' in treating tamoxifen-resistant breast cancer in postmenopausal women. The new treatment is given as a once a month intramuscular injection, which may offer compliance benefits and, as an endocrine treatment, 'Faslodex' does not cause the side effects commonly associated with chemotherapy. 'Faslodex' is an antioestrogen (oestrogen receptor antagonist) without known agonist effects. Unlike aromatase inhibitors that reduce the amount of oestrogen in a woman's body, and tamoxifen which blocks the oestrogen receptor, 'Faslodex' targets and degrades the oestrogen receptors in breast cancer cells. It is the only antioestrogen in general clinical use to have demonstrated efficacy following tamoxifen failure, indicating that it works in a different way to tamoxifen. 'Faslodex' therefore represents another approach to treating hormone sensitive breast cancer. 'Faslodex' and 'Arimidex' are trademarks, the property of the AstraZeneca group of companies. 25 April 2002 Media Enquiries: Emily Denney, Tel: +44 (0) 207 304 5034 Steve Brown, Tel: +44 (0) 207 304 5033 Investor Relations: Mina Blair Robinson, Tel: +44 (0) 207 304 5084 Jonathan Hunt, Tel: +44 (0) 207 304 5087 - Ends - This information is provided by RNS The company news service from the London Stock Exchange This information is provided by RNS The company news service from the London Stock Exchange

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AstraZeneca (AZN)
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