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Arimidex Gets FDA Fast Track Designation for Early Breast Cancer

Arimidex Gets FDA Fast Track Designation for Early Breast Cancer

WILMINGTON, Delaware—The US Food and Drug Administration (FDA) has granted fast track designation for AstraZeneca’s Arimidex (anastrozole) for the adjuvant treatment of postmenopausal women with early-stage breast cancer. The decision followed the release of data from the ATAC (Arimidex, Tamoxifen, Alone or in Combination) study at the 24th San Antonio Breast Cancer Symposium.

Arimidex is currently approved in the United States for use in advanced breast cancer in postmenopausal women.

Fast track designation allows for a rolling submission of data and expedited review of documents for the supplementary license application for Arimidex. Fast track status is granted for products that may offer significant improvements in how a serious disease is treated.

AstraZeneca has already begun to provide the FDA with data for the supplementary application and plans to complete the rolling submission by the end of February 2002.

The ATAC study involved 9,366 postmenopausal patients with early-stage breast cancer who had completed surgery and chemotherapy (if given) and were candidates for adjuvant hormonal therapy. After a median of 33 months follow-up and a median duration of treatment of 31 months, 317 of 3,125 women in the Arimidex group had a relapse of their breast cancer or died, compared with 379 of 3,116 women in the tamoxifen (Nolvadex) group (P = .0129).

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