WILMINGTON, Del., Sept. 10 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) 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)
"This approval is an important advancement for women with metastatic breast cancer, where the treatment approach is centered on delaying disease progression," said Gershon Locker, M.D., Medical Director for AstraZeneca. "FASLODEX at 250mg has been an important treatment option for many women, and we now have data to show that the new 500mg dosing regimen can improve progression free survival compared with the 250mg dose."
The recommended dose of FASLODEX 500mg should be administered intramuscularly into the buttocks as two 250mg injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter. A dose of 250mg is recommended in patients with moderate hepatic impairment.(1)
FASLODEX 500mg will be supplied as 2 x 250mg/5mL packaged together in early fourth qu