- The European Commission (EC) approves AstraZeneca's (AZN +0.5%) FASLODEX (fulvestrant) for the treatment of estrogen receptor-positive locally advanced or metastatic breast cancer in postmenopausal women who have not received prior endocrine therapy.
- The EC based its decision on the successful outcome of the Phase 3 FALCON study that showed the superiority of FASLODEX over anastrozole (ARIMIDEX) in a first-line setting in postmenopausal women with locally advanced or hormone receptor-positive (HR+) breast cancer who had not received prior hormone-based therapy.
- FASLODEX was previously approved to treat relapsed/refractory breast cancer patients who received prior anti-estrogen therapy.