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
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.
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.