AstraZeneca has found that faslodex 500mg (fulvestrant) is demonstrating better results than arimidex 1mg (anastrozole) while treating locally-advanced or metastatic breast cancer in post-menopausal women, who have not had prior hormonal treatment for hormone-receptor-positive (HR+) breast cancer during a Phase III trial (FALCON).
Advanced breast cancer (ABC) is the most advanced stage of breast cancer and happens when cancer cells have spread beyond the initial tumour site to other parts of the body outside of the breast.
The randomised, double-blind, multicentre Fulvestrant and AnastrozoLe Compared in hormonal therapy Naïve advanced breast cancer (FALCON) Phase III trial showed superiority of faslodex 500mg compared with arimidex 1mg, and met its primary endpoint of extended progression-free survival.
FALCON showed an adverse event profile generally consistent with existing knowledge of the safety profile of faslodex 500mg and arimidex 1mg.
Faslodex 500mg is designated to treat postmenopausal women with oestrogen-receptor (ER) positive, locally-advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.
In the US, Faslodex 500mg, along with palbociclib, is approved to treat women with hormone-receptor (HR) positive, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer, whose cancer has progressed after endocrine therapy.
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Aromatase inhibitors including arimidex are the existing standard of care in first-line treatment for postmenopausal women with advanced HR+ breast cancer.
AstraZeneca global medicines development executive vice-president and chief medical officer Sean Bohen said: "The FALCON results bring us closer to offering more and earlier treatment options to postmenopausal women with HR+ locally-advanced or metastatic breast cancer; the potential to delay disease progression is important for these patients as there is currently no cure.
"Faslodex has more than ten years of clinical evidence and we are committed to exploring its potential along with the rest of our outstanding oncology portfolio."
The company expects to present full results of the trial in this year.