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FDA Approves New Dosing for FASLODEX® (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women
Date:9/10/2010

arter 2010. During this time, FASLODEX 250mg will still be available.

According to data from the U.S. National Cancer Institute, more than 207,000 American women will be diagnosed with breast cancer in 2010.(3) Approximately 155,000 women in the United States are currently living with metastatic breast cancer, and this number is projected to increase to nearly 162,000 by the year 2011.(4)

The CONFIRM study, presented for the first time at the annual San Antonio Breast Cancer Symposium (SABCS) in December 2009, showed FASLODEX 500mg reduced the risk of disease progression (assessed as progression free survival) by 20 percent (HR 0.80; 95% CI 0.68-0.94, p=0.006) when compared with FASLODEX 250mg. FASLODEX 500mg significantly increased median progression free survival to 6.5 months vs. 5.4 months with 250mg (p=0.006).

Objective Response Rates calculated in patients with measurable disease was not significantly different between FASLODEX 500mg (13.8%) and 250mg (14.6%) (HR=0.94; 95% CI: 0.57-1.55) (p=0.795).  Median overall survival was 25.1 months with FASLODEX 500mg and 22.8 months with 250mg (HR=0.84; 95% CI: 0.69-1.03) (p=0.091).  At the time of analysis, overall survival was not statistically significant. A pre-planned second survival analysis will occur as data mature when approximately 75% of patients have had an event.  

Important Safety Information About FASLODEX® (fulvestrant) Injection

FASLODEX is contraindicated in patients with known hypersensitivity to the drug or to any of its components. Hypersensitivity reactions, including urticaria and angioedema have been reported in association with FASLODEX.

Because FASLODEX is administered intramuscularly, it should be used with caution in patients with bleeding diatheses, thrombocytopenia, or in patients on anticoagulants. FASLODEX is metabolized primarily in the liver. A 250-mg dose is recommended in patients with moderate hepatic impairment. F
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SOURCE AstraZeneca
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