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| |  FDA Approves New Use For Breast Cancer Drug Nolvadex (Tamoxifen) WILMINGTON, DE -- July 3, 2000 -- AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved its breast cancer drug Nolvadex® (tamoxifen citrate) to reduce the risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS) following breast surgery and radiation. Nolvadex is the first medication to be approved for DCIS, which accounts for nearly 20 percent of all newly diagnosed breast cancer cases.(1) "The approval of tamoxifen to reduce the risk of invasive breast cancer in women with DCIS is an important advance in the management of breast cancer," said Monica Morrow, M.D., Director, Lynn Sage Breast Center and Professor of Surgery, Northwestern University Medical School. "As more women have routine mammograms, breast cancer is being detected much earlier. These women now can take a drug that, when added to breast surgery and radiation, has been proven to reduce the likelihood that the cancer will spread or recur." DCIS is a non-invasive breast cancer involving only the cells lining milk ducts in the breast with no evidence that the disease has spread outside of these ducts.(2) Until the 1980's, DCIS was treated by mastectomy. Today, options also include lumpectomy, or lumpectomy plus radiation therapy. "The effectiveness of Nolvadex has now been proven across all stages of the breast cancer continuum from risk reduction in women at high risk to the treatment of advanced breast cancer," said Jerry P. Lewis, MD, Senior Director, Clinical Research, Oncology of AstraZeneca filed a supplemental new drug application with the FDA for the DCIS indication in December 1999, and was granted priority review in March 2000. The FDA submission was based on data from a study conducted by NSABP(3) and published in The Lancet that included 1,804 women with DCIS who had a lumpectomy and radiation therapy. Half of those patients were prescribed tamoxifen and half received a placebo. After an average follow-up period of more than five years, the researchers found that the addition of tamoxifen to the treatment regimen significantly reduced the incidence of invasive breast cancer by 43 percent among women assigned to Nolvadex (44 cases - Nolvadex, 74 cases placebo - p=0.004). Survival was similar in the placebo and Nolvadex groups. Nolvadex has been used for over 20 years to treat breast cancer; it is also available by prescription to women 35 years and older at high risk for breast cancer; and Nolvadex is now available for the management of DCIS in women who are also at high risk for breast cancer. In clinical trials with Nolvadex therapy, the risk of endometrial cancer and blood clots in the lung and legs increased approximately two to three times compared to placebo, although each event occurred in less than 1 percent of women. Stroke, cataracts, and cataract surgery occur more frequently with Nolvadex. More common side effects are vaginal discharge and hot flashes. Women who are pregnant or plan to become pregnant should not take Nolvadex. Women who have a history of blood clots or who use warfarin or coumarin to thin their blood should not take Nolvadex to reduce their incidence of breast cancer if they are at high risk or have DCIS. Notes: Related Links: Nolvadex (tamoxifen citrate) and AstraZeneca.
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