WILMINGTON, DelawareThe 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).