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FDA Approves Nolvadex For Breast Cancer Prevention In High-Risk Women WILMINGTON, DE -- Oct. 29, 1998 -- The United States Food and Drug Administration has approved Zeneca Pharmaceuticals’ breast cancer drug Nolvadex(R) (tamoxifen citrate) for the reduction in the incidence of breast cancer in women at high risk for developing the disease. The new indication makes Nolvadex the first and only drug to be approved to reduce the incidence of breast cancer. The FDA also approved a second new indication for Nolvadex for the reduction of contralateral (in the opposite breast) breast cancer, adding important new breast cancer treatment information to the Nolvadex label. Current data from clinical trials were also added that support five years of adjuvant Nolvadex therapy for patients with breast cancer. The FDA actions are based on the landmark results announced April 6, 1998 from the Breast Cancer Prevention Trial (BCPT) conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) and sponsored by the National Cancer Institute (NCI) which concluded that women taking Nolvadex reduced their incidence of developing invasive breast cancer on average by 44 percent. Updated results from the trial were recently published in the September issue of the Journal of the National Cancer Institute and concluded that the incidence of invasive breast cancer was reduced by 44 percent in women aged 35-49 years old, 51 percent for women aged 50-59 and 55 percent for women aged 60 and older. A reduction in the incidence of breast cancer was seen in all age groups starting as early as the first year of treatment and continuing through six years follow-up in those who began the trial in 1992 (median follow-up was 4.2 years). In order to identify those women who were at high risk of developing breast cancer, the BCPT used a statistical model using a combination of risk factors. This model called the Gail Model has been well-validated through clinical testing. Risk factors for breast cancer included in the model are: -- age (risk of breast cancer increases with age); -- number of first-degree relatives with breast cancer; -- previous breast biopsies with or without atypical hyperplasia; -- age at first live birth; -- age at first menstrual period; -- women with a history of lobular carcinoma in situ (LCIS); Nolvadex has been proven for over 20 years as a hormonal agent and is one of the most tested drugs in the world with extensive, long-term safety data. The most frequently reported adverse reactions with Nolvadex therapy were hot flashes and vaginal discharge. Although uncommon, endometrial cancer, deep vein thrombosis, pulmonary embolism, stroke, cataract formation and cataract surgery occurred more frequently with Nolvadex therapy than placebo. Endometrial cancer associated with Nolvadex treatment occurs in two to three women per 1,000 women per year. Current data indicates that healthy women in the general population have reported endometrial cancer of 0.7 cases per 1,000 per year. Women who are pregnant or who require concomitant coumarin-type anti-coagulant therapy or who have a history of deep-vein thrombosis or pulmonary embolus should not take Nolvadex to reduce their incidence of breast cancer. E-mail this page to a friend or colleague! To print, use this version