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| |  Arimidex (Anastrozole) Launched in Japan as Adjuvant Therapy in Early Breast Cancer LONDON, ENGLAND -- March 6, 2002 -- AstraZeneca announced today that its Japanese operating company has been able to lift the restriction to the Arimidex 1 mg prescribing information in Japan (JPI) regarding use of Arimidex (anastrozole) as adjuvant therapy, by notifying this amendment to the Japanese health authority (MHLW). With this action, and as of March 1 2002, Japan becomes the first world market to promote Arimidex as adjuvant therapy. Arimidex is already licensed worldwide for use in advanced disease. This important decision follows the exciting first results from the ATAC (Arimidex, Tamoxifen Alone or in Combination) study in this group of women, which showed that Arimidex significantly prolonged disease-free survival (DFS) compared to the gold-standard treatment, tamoxifen. Although Japan becomes the first market to promote Arimidex for early breast cancer, extended licence applications have already been submitted to the US Food and Drug Administration (FDA) and European regulatory authorities. Last month, AstraZeneca announced that the FDA had granted 'fast track' designation for the supplementary licence application in the US. The company anticipates early breast cancer licence approvals in the US, Europe and rest of world markets later this year. Presented for the first time in December last year at the San Antonio Breast Cancer Meeting, the ATAC study demonstrated that Arimidex is not only significantly more effective than tamoxifen in terms of DFS, but also that it has a number of important tolerability benefits over the current gold standard. These include a significant reduction in both the incidence of endometrial cancer and thromboembolic events. This is the first time ever that the established benefits of tamoxifen in early breast cancer have been surpassed by another treatment, and it marks an incredibly important breakthrough in the management of this increasingly prevalent disease. The ATAC study is the largest adjuvant breast cancer trial ever conducted. Welcoming this first launch for Arimidex in early breast cancer, Dr. George Blackledge, Vice-President and Medical Director of Oncology at AstraZeneca commented "It is excellent news that we are starting to bring the proven benefits of Arimidex to the many women newly diagnosed with early stage breast cancer. The results of ATAC are truly groundbreaking for the management of this devastating disease, and we look forward to further licence approvals in other markets in the future".
Efficacy data The ATAC results demonstrated a 17 percent reduction in the risk of breast cancer recurring with Arimidex treatment compared with tamoxifen, after a median of 33 month’s follow-up and a median treatment duration 30.7 months. Only 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 group (p=0.0129; HR=0.83, CI =0.71-0.96). Among women with confirmed hormone-sensitive tumours*, the reduction in risk with Arimidex compared with tamoxifen was even more striking, at 22 percent (p=0.0054; HR= 0.78, CI 0.65-0.93).
Safety / Tolerability data Arimidex was found to have many important tolerability advantages over tamoxifen: remarkably, it was associated with significantly fewer reports of endometrial cancer when compared with tamoxifen (0.5 percent vs <0.1 percent). This finding was supported by a significantly lower incidence of vaginal bleeding among Arimidex treated patients compared to those taking tamoxifen (8.2 percent vs 4.5 percent). Deep vein thrombosis was reported in almost twice as many patients taking tamoxifen compared with Arimidex patients (1.7 percent vs 1.0 percent). Another important outcome, particularly from the patient’s perspective, was a significantly reduced incidence of hot flushes (39.7 percent vs 34.3 percent) and weight gain (11.0 percent vs 9.2 percent) in favour of Arimidex over tamoxifen. However, as expected, women taking tamoxifen did have a lower risk of experiencing musculo-skeletal disorders (21.2 percent vs 27.8 percent) and the types of fractures common in this age group compared with those taking Arimidex (5.9 percent vs. 3.7 percent). Arimidex is licensed for use in the first- and second-line treatment of advanced breast cancer in postmenopausal women. Other than in Japan, it is not currently licensed for adjuvant use in early breast cancer.
*Tumours known to be oestrogen receptor (ER) and/or progesterone receptor (PR) positive. Arimidex is a trademark, property of the AstraZeneca Group of Companies. SOURCE: AstraZeneca
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