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| |  Astrazeneca Granted U.S. Approval For Arimidex (Anastrozole) In Early Breast Cancer Arimidex becomes the first and only hormonal agent other than tamoxifen approved for early stage breast cancer for postmenopausal women
WILMINGTON, DE -- September 6, 2002 -- AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Arimidex® (anastrozole) for the adjuvant treatment of early breast cancer in postmenopausal women with hormone receptor-positive disease. The U.S. approval is based on the groundbreaking results from the ATAC (Arimidex and Tamoxifen, Alone or in Combination) study-the world's largest ever breast cancer trial - which showed significant efficacy and tolerability benefits of Arimidex over tamoxifen in this setting. Arimidex is the first and only aromatase inhibitor to be approved for use in the adjuvant treatment of early breast cancer in postmenopausal women. Arimidex is already licenced worldwide for use in advanced disease where it has become the world's leading aromatase inhibitor with over 600,000 patient years experience. "Since first seeing the strength of the ATAC results, we have worked quickly to seek extended licences for Arimidex, and bring the proven benefits of the drug to the many postmenopausal women newly diagnosed with early stage breast cancer," said Bernie Tyrrell Vice President Marketing, AstraZeneca Oncology. "We believe that the results of the ATAC study are truly groundbreaking for the management of this devastating disease, and we look forward to further licence approvals in other markets in the future." Arimidex has already been approved as an adjuvant treatment for postmenopausal women with early breast cancer in Belgium and Mexico and, additionally, AstraZeneca has a licence to promote this indication in Japan. AstraZeneca submitted data packages requesting approval for Arimidex in early breast cancer in Europe and in other rest of world markets earlier this year. Arimidex sales in 2001 were $191 million, a 22 percent increase over the previous year. AstraZeneca's Nolvadex (tamoxifen) accounted for $630 million in sales the same year. The early breast cancer market could be worth approximately $2 billion. The ATAC study - which is now published as a peer-reviewed paper in the Lancet - demonstrated that Arimidex is more effective than tamoxifen in terms of disease free survival. The findings represent a 17% relative risk reduction for breast cancer recurrence with Arimidex treatment compared to tamoxifen. Among women confirmed with hormone-sensitive tumours, the reduction in relative risk with Arimidex compared with tamoxifen was even more striking, at 22%. Additionally, Arimidex shows an important benefit in reducing the likelihood of the cancer spreading to the opposite breast ('contralateral' breast cancer). Compared with tamoxifen (which had already shown an almost 50% reduction in this area versus control), Arimidex reduces the risk by a further 58%. Arimidex was also found to have many important tolerability advantages over tamoxifen. These include a significant reduction in the incidence of endometrial cancer, thromboembolic events, including deep vein thromboses and strokes, vaginal bleeding, and hot flushes. As expected, musculo-skeletal disorders and fractures were seen less frequently in patients treated with tamoxifen than with Arimidex. The published results are from the first planned analysis of the ATAC data at a median duration of 33.3 months follow-up. Additional follow-up for safety and efficacy is protocolled in the trial. "With the approval of Arimidex in the adjuvant, early stage setting, women now have a treatment option other than tamoxifen," said principal U.S. investigator Aman Buzdar, MD, the University of Texas, M.D. Anderson Cancer Center, Houston, Texas. "I encourage clinicians to discuss the ATAC trial results and their implications with all their patients." AstraZeneca (NYSE:AZN) is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of gastrointestinal, oncology, anesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. Arimidex and Nolvadex are trademarks, the property of the AstraZeneca group of companies.
SOURCE: AstraZeneca
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