FDA Approves Fulvestrant Monotherapy for HR+/HER2- Breast Cancer
Study results demonstrated that progression-free survival (PFS) was significantly prolonged in the fulvestrant group compared to the anastrazole group.
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.