Approval for Faslodex in tamoxifen-resistant breast cancer

WILMINGTON, DEL. -- The FDA has granted approval to AstraZeneca for the new breast cancer drug Faslodex (fulvestrant) Injection for treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following anti-estrogen therapy, such as tamoxifen.

Faslodex is an estrogen receptor antagonist without known agonist effects. It is the only estrogen receptor antagonist to be proven effective after tamoxifen failure.

Currently, advanced breast cancer patients whose tumors have been shown to depend on hormones to grow, may be 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.

Faslodex is a hormonal therapy that works by binding, blocking and degrading the estrogen receptor, and does not cause the type of side effects commonly associated with cytotoxic chemotherapy. It is administered as a once monthly intramuscular injection, which may assist health care professionals in monitoring compliance, and may also make treatment more convenient for some patients.

"Faslodex provides an effective, new treatment option for women with advanced breast cancer whose tumors have become resistant to tamoxifen," said lead trial investigator C. Kent Osborne, M.D., Baylor College of Medicine, Houston, Texas. "We now may be able to control the breast cancer for a longer period of time."

"The management of advanced breast cancer has significantly improved through sequential treatment with different hormonal therapies. The introduction of Faslodex expands the number of options available for sequential treatment and provides women with a new drug that works in a different way," said Gerard T. Kennealey, M.D., Vice President of Clinical Research, Oncology, for AstraZeneca.

Faslodex can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while receiving Faslodex.

Posted: May 2002


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