AstraZeneca announced that the 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. This approval was based on data from CONFIRM (COmparisoN of Faslodex In Recurrent or Metastatic breast cancer), a Phase 3 study which demonstrated that Faslodex 500mg reduced the risk of disease progression (assessed as progression free survival) by 20% (p=0.006) when compared with Faslodex 250mg. Faslodex 500mg significantly increased median progression free survival to 6.5 months vs. 5.4 months with 250mg (p=0.006).

Objective Response Rates calculated in patients with measurable disease was not significantly different between Faslodex 500mg (13.8%) and 250mg (14.6%) (p=0.795). Median overall survival was 25.1 months with Faslodex 500mg and 22.8 months with 250mg (p=0.091). At the time of analysis, overall survival was not statistically significant. A pre-planned second survival analysis will occur as data mature when approximately 75% of patients have had an event.

Faslodex 500mg will be supplied as 2 x 250mg/5mL packaged together in early fourth quarter 2010. During this time, Faslodex 250mg will still be available.

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