'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."
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