The FDA has approved Faslodex (fulvestrant) injection for the treatment of hormone receptor-- positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy, such as tamoxifen. The only estrogen receptor antagonist to be proven effective after tamoxifen failure, Faslodex doesn't cause the adverse reactions commonly associated with cytotoxic chemotherapy. It's administered once monthly as an I.M. injection.
The FDA's approval of Faslodex was based on data from two Phase III randomized multicenter studies involving 851 patients. Its effectiveness when given as a 250-mg once-monthly injection was established by comparison with the selective aromatase inhibitor anastrozole (1 mg/day orally).
A product of AstaZeneca, Faslodex can cause fetal harm when administered to a pregnant woman. Warn women of childbearing potential not to become pregnant.
Copyright Springhouse Corporation Aug 2002
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