The FDA has approved label changes for AstraZeneca‘s Faslodex (fulvestrant) injection.

Labeling updates include 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 pivotal study supporting Faslodex 500mg. An updated OS analysis performed after a minimum follow-up duration of 50 months showed a 4.1 month difference in median OS when using Faslodex 500mg vs. 250 mg.

Faslodex, an estrogen receptor antagonist, is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

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