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AstraZeneca submits supplemental NDA to FDA for Arimidex.(New Drug Application )(Brief Article)
2002 APR 4 - (NewsRx.com & NewsRx.net) -- AstraZeneca announced that the submission of a supplemental New Drug Application (sNDA), with the U.S. Food and Drug Administration (FDA) has been completed for Arimidex (anastrozole) for treatment of early breast cancer in postmenopausal women.
The company is requesting Priority Review, having received Fast Track Designation for this submission on December 21, 2001, from the FDA based on data from the ATAC (Arimidex and Tamoxifen, Alone or in Combination) study, the largest breast cancer treatment trial ever conducted. Arimidex is currently approved in the U.S. for use in advanced breast cancer in postmenopausal women. The FDA grants Priority Review status for products that may offer significant improvements in the treatment of serious diseases.
Results from the ATAC trial, presented last December at the San Antonio Breast Cancer Symposium, reported for the first time the effect of Arimidex as an adjuvant treatment in postmenopausal women with early breast cancer. After a median of 33.3 months follow-up and a median duration of treatment of 30.7 months, 317 of 3125 women in the Arimidex group had a relapse of their breast cancer or died, compared with 379 of 3116 women in the tamoxifen group (p=0.0129). This represents a 17% reduction in the risk of disease recurrence with Arimidex treatment compared with tamoxifen. The reduction in the risk of recurrence was 22% in women with confirmed hormone-sensitive tumors with Arimidex treatment compared with tamoxifen (p=0.0054). The incidence of contralateral breast cancer, a secondary endpoint in the trial, was 14 of 3,125 women with Arimidex and 33 of 3116 women with tamoxifen, a 58% reduction in incidence. Study results showed that the Arimidex/tamoxifen combination was no more effective than tamoxifen alone.
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Source: HighBeam Research, AstraZeneca submits supplemental NDA to FDA for Arimidex.(New Drug...