WILMINGTON, Del., Sept. 10 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE:AZN - News) today announced that the U.S. Food and Drug Administration (FDA) has approved the 500mg dose of FASLODEX® (fulvestrant) Injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.(1) The FDA approval of FASLODEX 500mg was based on results from CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer), a Phase III study which demonstrated that FASLODEX 500mg significantly reduced the risk of disease progression in patients with metastatic breast cancer, when compared with the 250mg dose. Safety and tolerability profiles of both doses were comparable.(2)
