AstraZeneca has received US Food and Drug Administration (FDA) approval for a 500mg dose of its Faslodex (fulvestrant) injection for the treatment of metastatic breast cancer in postmenopausal women.
FDA approval was granted on the basis of a double-blind, randomised, parallel-group and multi-centre Phase III trail that compared the 500mg and 250mg doses of Faslodex.
The study found that the 500mg dose significantly reduced the risk of disease progression in patients with hormone receptor-positive metastatic breast cancer compared with the 250mg dose.
Faslodex 500mg also increased median progression-free survival to 6.5 months, compared with 5.4 months with the 250mg dose.
Median overall survival with Faslodex 500mg was 25.1 months compared with 22.8 months with the 250mg dose.
Faslodex 500mg will be available in the early fourth quarter 2010.