ARIMIDEX RECEIVES FULL FDA APPROVAL
The FDA has granted full approval status to AstraZeneca's Arimidex (anastrozole)
for the adjuvant treatment of hormone receptor-positive early breast cancer
in postmenopausal women.
In September 2002, the FDA approved a supplemental new drug application (sNDA) for Arimidex under the provisions for accelerated approval, with further follow-up required for full approval. The supplemental approval was based on recurrence-free survival data from the Arimidex Tamoxifen Alone or in Combination (ATAC) trial with a median duration treatment of 31 months.
Complete five-year data from the ATAC trial was published in December 2004 in The Lancet. The data, which satisfied the FDA's request for five years of follow-up, indicated that Arimidex significantly reduced the relative risk of breast cancer recurrence by 17 percent over tamoxifen in the clinically relevant hormone receptor-positive patients for whom Arimidex is indicated.