FDA Approves Fulvestrant as Monotherapy for Expanded Use 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, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer who have gone through menopause and have not received previous endocrine therapy. The FDA approval is based on data from the phase III FALCON trial, which were published in the November 2016 issue of The Lancet by Robertson et al.

Jamie Freedman, Executive Vice President and Head of the Oncology Business Unit at AstraZeneca, said, “We’re pleased that the landmark FALCON trial results demonstrated the efficacy of fulvestrant as initial monotherapy treatment for women who are living with hormone receptor–positive, HER2-negative advanced breast cancer. This approval, building on more than 15 years of clinical experience, means more patients can have the opportunity to receive fulvestrant earlier in the treatment journey.”

Matthew Ellis, MD, PhD, Director of the Lester and Sue Smith Breast Center, part of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, said, “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 FALCON Trial

The FALCON trial was designed to demonstrate superiority and included 462 postmenopausal women with hormone receptor–positive metastatic or locally advanced breast cancer.

The results showed a statistically significant increase in investigator-assessed median progression-free survival, representing a 20% reduction in the risk of disease progression or death, with a median progression-free survival of 16.6 months in patients who received fulvestrant compared to 13.8 months in patients receiving the aromatase inhibitor anastrozole at 1 mg (hazard ratio [HR] = 0.797; 95% confidence interval [CI] = 0.637–0.999; P = .049). The most common adverse reactions (≥ 10%) of any grade reported in patients in the fulvestrant arm were arthralgia, hot flash, fatigue, and nausea.

Fulvestrant is a hormonal therapy that targets the estrogen receptor, which can influence the growth of hormone receptor–positive metastatic breast cancer and helps to slow cancer growth by blocking the estrogen receptor and targeting it for degradation. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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