AstraZeneca files for Faslodex in USA

29 March 2001

AstraZeneca has filed for approval to market its estrogen receptordown-regulator Faslodex (fulvestrant; formerly ICI182,780) in the USA for the treatment of locally-advanced or metastatic breast cancer in postmenopausal women who have previously progressed following hormonal therapy. The drug is administered via a monthly intramuscular injection.

This is the first filing for the drug which, if approved, would add another weapon to the anti-estrogen armamentarium used in the management of breast cancer, currently represented by estrogen-receptor blockers and aromatase inhibitors. Sequential treatment with different hormonal therapies is an accepted and successful strategy in breast cancer and Faslodex, working by a different mode of action, offers an option in patients whose cancers have stopped responding to front-line therapies. AstraZeneca is asking the US Food and Drug Administration to grant Faslodex a priority review.

The company has completed two Phase III clinical trials of Faslodex in breast cancer, looking at the drug's effects in post-menopausal women with advanced disease, most of whom had received hormonal treatment with AstraZeneca's long-standing estrogen-receptor blocker Nolvadex (tamoxifen). Both trials, one conducted in North America and the other in Europe, compared the new drug to AstraZeneca's leading aromatase inhibitor Arimidex (anastrozole).

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