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)
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“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
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