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FDA Approves Expanded Use of Fulvestrant as Monotherapy in Breast Cancer

On August 28, the U.S. Food and Drug Administration (FDA) approved fulvestrant (Faslodex) at 500 mg as monotherapy for expanded use in women with hormone–receptor positive, HER2-negative advanced breast cancer who have gone through menopause and have not received previous endocrine therapy. This approval is based on data from the phase III FALCON trial, which was published in The Lancet by John F. R. Robertson, MD, of the University of Nottingham, Royal Derby Hospital Centre, Derby, UK, and colleagues.

Matthew Ellis, MD, PhD, Director of the Lester and Sue Smith Breast Center, commented on this approval in a recent press release: “This study provides evidence that using fulvestrant as the first option for previously untreated hormone receptor–positive advanced breast cancer will prolong the time before the disease advances and alternative therapies are required.”

The international, randomized FALCON trial included 462 postmenopausal women with hormone receptor–positive metastatic or locally advanced breast cancer. A statistically significant increase in investigator-assessed median progression-free survival was reported with fulvestrant compared with the aromatase inhibitor anastrozole (16.6 vs. 13.8 months). This represented a 20% reduction in the risk of disease progression or death. Arthralgia, hot flashes, fatigue, and nausea were the most common adverse reactions observed in the fulvestrant arm.