FDA grants AstraZeneca priority review for Nolvadex

® FDA GRANTS ASTRAZENECA PRIORITY REVIEW FOR NOLVADEX FOR TREATMENT OF DUCTAL CARCINOMA IN SITU (DCIS), A COMMON TYPE OF NON-INVASIVE BREAST CANCER The U.S. Food and Drug Administration (FDA) has granted a six-month @ priority review to AstraZeneca's breast cancer drug NOLVADEX (tamoxifen citrate) for the adjuvant treatment of ductal carcinoma in situ (DCIS) in women following breast surgery and radiation. AstraZeneca filed a supplemental new drug application with the FDA for the DCIS indication in December 1999. Currently, there is no medication approved by the FDA for the adjuvant treatment of DCIS. DCIS accounts for nearly 20 per cent of all newly 1 diagnosed breast cancer cases. "If approved for this indication, NOLVADEX's effectiveness will have been demonstrated across several stages of the breast cancer continuum from risk reduction in women at high risk to advanced breast cancer," said Gerard Kennealey, Vice President of Medical Oncology. 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 2 of these ducts. Until the 1980's, DCIS was treated by mastectomy. Today, options also include lumpectomy, or the preferred method of lumpectomy plus radiation therapy. .../cont'd The FDA submission was based on data from a study, B-24, conducted by the 3 National Surgical Adjuvant Breast and Bowel Project (NSABP). The study, published in the June 12,1999, Lancet 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 five-year incidence of invasive cancer in the same breast by 44.8 percent (29 cases on placebo vs. 16 cases on tamoxifen - p<0.04). Additionally, the researchers analysed the occurrence of all new breast cancer events including contralateral (in the opposite breast) breast cancer and new non-invasive breast cancers. They found that the addition of tamoxifen reduced the five-year incidence of a new breast cancer by 31.7 per cent (104 cases on placebo vs. 71 cases on tamoxifen - p<0.007). Physicians regard DCIS as a clinical "marker" indicating that changes 4 are occurring in a woman's breast that could lead to invasive cancer. For this reason, the goal of treatment for DCIS is not only to treat the disease itself, but to also address a woman's risk status for developing future invasive lesions in the same or opposite breast. If DCIS cells travel beyond the ducts into the surrounding tissue, they become invasive breast cancer. .../cont'd Further enquires to: Steve Brown, tel +44 171 304 5033 Lucy Williams, tel +44 171 304 5034 Staffan Ternby, tel +46 8 553 261 07 Mikael Widell, tel +46 8 553 264 28 / 070-311 99 60 1 Breast Cancer Facts and Figures 1999-2000. American Cancer Society 2 Love, Susan M. MD. Dr. Susan Love's Breast Book. Massachusetts: Addison-Wesley Publishing Company 1995. 3 Fisher et. al. Tamoxifen in Treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 Randomized Controlled Trial . The Lancet Vol. 353 June 12, 1999. 4 Morrow, M. et. al. Ductal Carcinoma In Situ and Microinvasive Carcinoma. Diseases of the Breast. Lippincott Williams and Wilkins: Philadelphia. 2000. Notes to Editors: ® NOLVADEX has been used for over 20 years to treat breast cancer and is one of the most tested drugs in the world with extensive, long-term safety data. AstraZeneca continues its tradition of research excellence and innovation in Oncology. Anti-cancer therapies for breast include ® ® NOLVADEX (tamoxifen citrate) Tablets; ARIMIDEX (anastrozole) Tablets; ® and ZOLADEX (goserelin acetate implant). Anti-cancer therapies for prostate include CASODEX® (bicalutamide) 50-mg Tablets; and ZOLADEX®. AstraZeneca has many promising new oncology therapies in development including FASLODEX (fulvestrant), a selective estrogen receptor down- regulator (S.E.R.D.), a new class in development for advanced breast cancer; IRESSA® (ZD1839), an epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TK), under investigation for various cancers ® including small cell lung cancer; and TOMUDEX (raltitrexed), a thymidylate synthase inhibitor, under investigation for the palliative treatment of advanced colorectal cancer. AstraZeneca 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 $15 billion and leading positions in sales of gastrointestinal, oncology, anesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/03/14/20000314BIT00140/bit0001.doc http://www.bit.se/bitonline/2000/03/14/20000314BIT00140/bit0002.pdf