FDA Expands Approval of Faslodex
The US Food and Drug Administration recently expanded the approval of Faslodex (fulvestrant) 500 mg to allow its use as a monotherapy for the treatment of hormone-receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer in postmenopausal women who have not received prior treatment.
Cholesterol-Lowering Medication Improves Breast Cancer Outcomes
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Approval for Faslodex was based on data from the Phase III FALCON trial, which include 462 postmenopausal women with HR+ metastatic or locally-advanced breast cancer. Women who received Faslodex experienced a median 16.6 months of progression-free survival compared with 13.8 months for patients who received anastrozole.
Common adverse reactions included arthralgia, hot flashes, fatigue, and nausea.
—Melissa Weiss
Reference:
Faslodex receives US FDA approval as monotherapy for expanded use in breast cancer [press release]. AstraZeneca, August 28, 2017. https://www.astrazeneca.com/media-centre/press-releases/2017/faslodex-receives-us-fda-approval-as-monotherapy-for-expanded-use-in-breast-cancer.html. Accessed August 28, 2017.