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Title: AstraZeneca Receives FDA Approval For Faslodex - A New Type Of Breast Cancer Treatment For Tamoxifen Resistant Breast Cancer

"AstraZeneca Receives FDA Approval For Faslodex - A New Type Of Breast Cancer Treatment For Tamoxifen Resistant Breast Cancer"

'Faslodex' (fulvestrant) - First of A New Type of Breast Cancer Treatments LONDON, ENGLAND -- April 26, 2002 -- The U.S. Food and Drug Administration (FDA) has granted marketing approval to AstraZeneca for its new breast cancer drug 'Faslodex' (fulvestrant) for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antioestrogen therapy (e.g. tamoxifen). Two pivotal Phase III trials showed 'Faslodex' to be at least as effective as the aromatase inhibitor 'Arimidex' (anastrozole) in treating tamoxifen resistant breast cancer in postmenopausal women. The new treatment is administered as a once a month intramuscular injection, which may offer compliance benefits and since it is an endocrine treatment, it does not cause the side effects commonly associated with chemotherapy. Commenting on today's announcement from the FDA, lead US 'Faslodex' trial investigator C. Kent Osborne, M.D., from Baylor College of Medicine, Houston, Texas, said, "Faslodex provides an effective, new treatment option for women with advanced breast cancer whose tumours have become resistant to tamoxifen. "When you have a new drug like Faslodex that we can now add to that sequence of drugs, we may be able to control the breast cancer for a longer period of time." '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 after tamoxifen failure, indicating that it works in a different way to tamoxifen. 'Faslodex' therefore represents another approach to treating hormone sensitive advanced breast cancer. "Advanced breast cancer treatment has significantly improved through sequential treatment with different and novel hormonal therapies. The introduction of 'Faslodex' expands that sequence, providing women with another treatment option that works in an uniquely different way," said Dr. George Blackledge, VP, Medical Director of Oncology, AstraZeneca. The FDA approval was based on data from two Phase III, randomised, multi-centre studies comparing 'Faslodex' 250mg once monthly injection to daily 1mg oral 'Arimidex', the most commonly prescribed hormonal treatment for advanced breast cancer in women who have previously progressed following tamoxifen therapy. All women in the trials (851 patients total) were postmenopausal and had been treated with one prior hormonal therapy, in most cases tamoxifen, and were randomised after their disease had progressed. The studies found that 'Faslodex' was at least as effective as 'Arimidex', in time to progression, and objective response rate. In both studies, 'Faslodex' showed a duration of response which was significantly longer than with 'Arimidex'*. In these clinical trials, both treatments were well tolerated. Commonly reported adverse experiences with 'Faslodex', which occurred with a similar incidence to 'Arimidex' included hot flushes, nausea, asthenia and headache. Injection site reactions, which were generally mild and transient occurred in only 1% of the injections given. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of oncology, gastroenterology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. 'Faslodex' and 'Arimidex' are trademarks, the property of the AstraZeneca group of companies. *Based on the mean duration of response in all patients measured from the onset of response. For further information, please contact: Paul Olaniran, AstraZeneca International Headquarters, Alderley Park, Macclesfield, Cheshire, UK. Tel; +44 (0) 1625 513980 Louise Marland, AstraZeneca International Headquarters, Alderley Park, Macclesfield, Cheshire, UK. Tel: +44 (0) 1625 510782, Mobile: 07900 607794 or Matt de Gruchy, Shire Health International, London, UK, Tel: +44 (0)20 7471 1500 Visit www.BrCaWatch.com and www.cancerpressoffice.com for more news and information about hormonal therapy and breast cancer SOURCE: Shire Health International

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