The US Food and Drug Administration expanded the indications for fulvestrant to include monotherapy for treatment-naive, menopausal patients with hormone-receptor positive (HR+), human epidermal growth factor 2 negative (HER2-) advanced breast cancer.1
Fulvestrant was previously approved as monotherapy in patients with HR+ metastatic breast cancer who had progressed after antiestrogen therapy, and in combination with palbociclib in treating patients with HR+/HER- advanced or metastatic breast cancer who had progressed after endocrine therapy.
The FDA based its approval on results from the phase 3 FALCON trial (ClinicalTrials.gov Identifier: NCT01602380), for which researchers randomly assigned 462 women with HR+ local or advanced breast cancer who were endocrine therapy naive to receive 500 mg of intramuscular fulvestrant or 1 mg oral anastrazole.
Study results demonstrated that progression-free survival (PFS) was significantly prolonged in the fulvestrant group compared to the anastrazole group (hazard ratio [HR], 0.797; 95% CI, 0.637-0.999; P = .0486). The fulvestrant arm had a median PFS of 16.6 months (95% CI, 13.83-20.99) compared to 13.8 months (95% CI, 11.99-16.59) in the anastrazole arm.
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Frequently reported adverse events (AE), which occurred in more than 10% of patients, included arthralgia, hot flashes fatigue, and nausea, and 7% and 5% of study patients in the fulvestrant and anastrazole groups, respectively, discontinued treatment due to adverse events.
- FASLODEX® (fulvestrant) Receives US FDA Approval as Monotherapy for Expanded Use in HR+, HER2- Advanced Breast Cancer [news release]. Wilmington, DE: BusinessWire; August 28, 2017. http://www.businesswire.com/news/home/20170828005319/en/FASLODEX%C2%AE-fulvestrant-Receives-FDA-Approval-Monotherapy-Expanded. Published August 28, 2017. Accessed August 28, 2017.