Breast Cancer

Anastrozole Receives FDA Fast-Track Designation For Early Disease

Published in Women's Health Weekly, February 7th, 2002

AstraZeneca announced January 15, 2002, that the U.S. Food and Drug Administration (FDA) has granted Fast-Track Designation allowing for a rolling submission of data and expedited review of documents for the supplementary license application for its drug Arimidex (anastrozole), for the treatment of postmenopausal women with early breast cancer.

This decision follows quickly after the release of data in December 2001 from the ATAC (Arimidex, Tamoxifen, Alone or in Combination) study - the largest adjuvant breast cancer trial ever conducted.

AstraZeneca has already begun to provide the FDA data and plans to complete the rolling submission for Arimidex...

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Source: Women's Health Weekly (2002-02-07)

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