AstraZeneca and US Food and Drug Administration (FDA) have agreed to update label for Faslodex (fulvestrant) injection.
The updated prescribing information for Faslodex US contains results and a Kaplan-Meier plot of the final overall survival (OS) analysis from CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer), the study that supported Faslodex 500 mg.
CONFIRM also demonstrated increased progression-free survival with a relative risk reduction of 20% when compared to Faslodex 250 mg.
The updated OS data has shown a 4.1 month difference in median OS when using Faslodex 500 mg in comparison to 250 mg.
FASLODEX 500 mg is used to treat hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
The Faslodex updated FDA label also includes information from an additional two-year carcinogenesis study conducted in rats and mice.
