FALCON Phase III trial shows Faslodex (fulvestrant) superior toArimidex (anastrozole) for the treatment of metastatic breast cancer-AstraZeneca

AstraZeneca announced positive results from the Phase III FALCON trial comparing Faslodex 500mg (fulvestrant) to Arimidex 1mg (anastrozole) for the treatment of locally-advanced or metastatic breast cancer, in post-menopausal women who have not had prior hormonal treatment for hormone-receptor-positive (HR+) breast cancer. Faslodex 500mg demonstrated superiority compared with Arimidex 1mg in FALCON, and met its primary endpoint of extended progression-free survival.

The trial showed an adverse event profile generally consistent with current knowledge of the safety profile of the medicines. A full evaluation of the data is ongoing and the results are expected to be presented at a medical meeting in 2016. Aromatase inhibitors (such as Arimidex) are the current standard of care in first-line treatment for postmenopausal women with advanced HR+ breast cancer. Faslodex 500mg is approved for the treatment of postmenopausal women with oestrogen-receptor (ER)-positive locally-advanced or metastatic breast cancer whose cancer has progressed following anti-oestrogen therapy. Most recently, on 2 March 2016, the FDA approved Faslodex 500mg, in combination with palbociclib, for the treatment of women with hormone-receptor-positive, human-epidermal-growth-factor-receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC), whose cancer has progressed after endocrine therapy.