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2001 APR 19 - (NewsRx.com & NewsRx.net) -- AstraZeneca announced on March 29, 2001, that it submitted a new drug application (NDA) requesting Priority Review with the U.S. Food and Drug Administration (FDA) for Faslodex[TM] (fulvestrant) for treatment of locally advanced or metastatic breast cancer in postmenopausal women who have previously progressed following hormonal therapy.
Faslodex is characterized as an estrogen receptor downregulator and works differently than other hormonal breast cancer drugs in that it targets and degrades the estrogen receptor. Currently, advanced breast cancer patients whose tumors have been shown to use hormones to grow, are given drugs like tamoxifen that act by blocking the estrogen receptor or aromatase inhibitors that lessen the amount of estrogen in a woman's body. After a period of time, tumors can become resistant to these types of treatments and cancer may progress.
The FDA submission was based on data from ...