> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves Faslodex/Palbociclib Combo Use in Cancer
- URL: https://www.fdaweb.com/fda-approves-faslodex-palbociclib-combo-use-in-cancer/
- Published: 2016-03-03T12:00:00.000Z
- Updated: 2026-09-15T02:40:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134958

> FDA has approved an expanded indication for AstraZeneca’s Faslodex (fulvestrant), for combination use with palbociclib in treating women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy. Single-therapy Faslodex has been approved since 2002 for treating postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy. “We believe that advances in cancer treatment will come, in part, from our research building upon existing treatments,” the company says.  
>  
> Approval was based on data from the Phase 3 PALOMA-3 trial, which met the study’s primary endpoint of progression-free survival (PFS). “The combination of FASLODEX 500 mg and palbociclib 125 mg resulted in a 4.9 month PFS improvement over FASLODEX and placebo, in women with HR+ HER2- advanced or MBC whose disease had progressed after endocrine therapy,” according to the company. “Improvement in PFS was seen irrespective of menopausal status.”