Fulvestrant Receives EC Approval as First-Line Therapy for Advanced Breast Cancer

On July 26, the European Commission (EC) approved fulvestrant (Falsodex) for the treatment of estrogen receptor–positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

The EC approval is based on pivotal data from the phase III FALCON trial, which demonstrated the superiority of fulvestrant at 500 mg over anastrozole at 1 mg as first-line treatment for postmenopausal women with locally advanced or hormone receptor–positive metastatic breast cancer who had not received prior hormone-based therapy.

FALCON Results

In the FALCON trial, median progression-free survival was significantly longer with fulvestrant than with the aromatase inhibitor anastrozole—16.6 months vs 13.8 months (hazard ratio = 0.797; 95% confidence interval = 0.637–0.999; P = .0486). Aromatase inhibitors such as anastrozole are the current standard of care for the first-line treatment of postmenopausal women with hormone receptor–positive advanced breast cancer.

Jamie Freedman, Executive Vice President and Head of AstraZeneca’s Oncology Business Unit, said, “This new EU approval shows the scientific strength of fulvestrant with more than 15 years of clinical experience. Postmenopausal women with hormone receptor­–positive advanced breast cancer can now benefit from fulvestrant at an earlier stage in their disease. We continue to explore the full potential of this important medicine as monotherapy and in combination with other medicines.”

Matthew Ellis, MD, PhD, study investigator and Director of the Lester and Sue Smith Breast Center in the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, said, “A 20% reduction in disease progression or death observed with fulvestrant compared to the current standard therapy is an advance in the management of postmenopausal women diagnosed with previously untreated hormone receptor–positive advanced breast cancer. The study provides evidence that the earlier use of fulvestrant in these patients will prolong the time before the disease progresses, which requires a change to a second line drug.”

The safety and tolerability profiles for fulvestrant and anastrozole reported in the FALCON trial were in line with current experience. The most commonly reported adverse events in the fulvestrant and anastrozole arms were arthralgia (16.7% vs 10.3%), hot flush (11.4% vs 10.3%), and nausea (10.5% vs 10.3%).

Fulvestrant is the only hormonal medicine for advanced breast cancer that slows tumor growth by binding to and degrading the estrogen receptor—a key driver of breast cancer progression in some women. It is widely approved for the treatment of hormone receptor–positive advanced breast cancer in postmenopausal women with disease progression following antiestrogen medicine.

Fulvestrant was first approved in 2002 and is currently being tested in combination with over 19 different medicines for the treatment of women with advanced hormone receptor–positive breast cancer.

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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