AstraZeneca receives FDA approval for Faslodex.

2002 MAY 30 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has granted approval to AstraZeneca (AZN) for their new breast cancer drug Faslodex (fulvestrant) Injection for treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen 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 healthcare 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 Faslodex trial investigator C. Kent Osborne, MD, Baylor College of Medicine, Houston, Texas. "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."

"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, MD, vice president of clinical research, oncology, for ...