The FDA approves the use of AstraZeneca's (NYSE:AZN) breast cancer med FASLODEX (fulvestrant), in combination with Pfizer's (NYSE:PFE) IBRANCE (palbociclib), for the treatment of 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.
The data supporting the approval was generated in the Phase 3 PALOMA-3 study that showed an average increase in progression-free survival (PFS) of 4.9 months in patients receiving FASLODEX/IBRANCE compared to FASLODEX/placebo in women with HR+ HER2- advanced or MBC whose disease had progressed after endocrine therapy. The positive effect on PFS was seen regardless of menopausal status.
The FDA cleared FASLODEX in 2002 as monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.
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