Anastrozole Receives FDA Fast-Track Designation For Early Disease.(AstraZeneca's Arimidex)

2002 FEB 7 - (NewsRx.com & NewsRx.net) -- 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 by the end of February 2002. The FDA grants fast-track status for products that may offer significant improvements in how a serious disease is treated. Arimidex is currently approved in the U.S. for use in advanced breast cancer in postmenopausal women.

"AstraZeneca is pleased by the FDA's decision to grant Arimidex fast-track status for early breast cancer," said Gerard T. Kennealey, MD, AstraZeneca. "We would like to thank the many women throughout the world who participated in this study and who made it possible to conduct this important research."

Presented in December 2001 at the San Antonio Breast Cancer Symposium, Texas, the ATAC study involved 9366 patients with early breast cancer who had completed surgery and chemotherapy (if given) and were candidates for adjuvant hormonal therapy. The study showed that after a median of 33.3 months follow-up and a median duration of treatment of 30.7 months, 317 of 3,125 women in the Arimidex group had a relapse of their breast cancer or ...