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Fulvestrant Added to National Comprehensive Cancer Network (NCCN) Guidelines

WILMINGTON, Del., April 24 /PRNewswire-FirstCall/ -- FASLODEX(R) (fulvestrant) Injection, the most recent hormonal treatment to receive approval in the U.S. for metastatic breast cancer, is now part of the National Comprehensive Cancer Network's (NCCN) "Practice Guidelines in Oncology for Breast Cancer." FASLODEX is included in their updated treatment protocol for subsequent hormonal therapy for invasive breast cancer in postmenopausal women following prior antiestrogen treatment, as reported in the April 2003 edition of the Journal of the National Comprehensive Cancer Network (JNCCN).

The "NCCN Practice Guidelines in Oncology for Breast Cancer" are widely recognized and used as a standard for clinical policy in cancer care. The guidelines represent a comprehensive evaluation of available scientific evidence and expert opinion in a consensus approach involving thought leaders from medical, surgical, and radiation oncology and other pertinent clinical areas.

FASLODEX is currently approved in the United States for treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy such as tamoxifen. It is an estrogen receptor antagonist without known agonist effects, and the only one to be proven effective after tamoxifen failure. FASLODEX works by finding estrogen receptors in the cancer cells and binding to them. In doing so, it keeps estrogen from binding to them. The binding of FASLODEX also causes the receptors to change shape and become less functional. In clinical studies of postmenopausal women with breast cancer, treatment with FASLODEX showed a decrease (downregulation) in the amount of estrogen receptors in breast cancer cells.

FASLODEX is administered as a once monthly intramuscular injection. The once monthly intramuscular injection route of administration allows health care professionals more opportunity for patient follow up.

"FASLODEX represents another option for treating women with advanced breast cancer," said Joseph Purvis, MD, Executive Director, Clinical Development, AstraZeneca Pharmaceuticals. "Its inclusion in the NCCN guidelines demonstrates its importance in the sequence of therapies used to treat women with hormone responsive breast cancer."

The NCCN guidelines are distributed free of charge to clinical professionals in the United States and internationally. An updated 2003 version of the NCCN "Practice Guidelines in Oncology for Breast Cancer" is online at .

FASLODEX is a prescription medication and is only for postmenopausal women. 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.

In clinical trials, the safety profile for FASLODEX was comparable to Arimidex(R) (anastrozole). The most commonly reported adverse events seen with FASLODEX vs. anastrozole treatment, regardless of the investigator's assessment of causality, were gastrointestinal symptoms (nausea 26.0% vs. 25.3%, vomiting 13.0% vs. 11.8%, constipation 12.5% vs. 10.6%, diarrhea 12.3% vs. 12.8%, abdominal pain 11.8% vs. 11.6%), headache (15.4% vs. 16.8%), back pain (14.4% vs. 13.2%), hot flushes (17.7% vs. 17.3%), and pharyngitis (16.1% vs. 11.6%). Injection site reactions with mild, transient pain and inflammation were reported in 7% of patients (1% of treatments) given single 5 mL and 27% of patients (4.6% of treatments) given 2 x 2.5 mL injections of FASLODEX.

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