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| |  Marketing Approval Submitted To FDA For Taxol Adjuvant Therapy In Breast Cancer PRINCETON, N.J. -- April 29, 1999 -- Bristol-Myers Squibb Company announced today (April 29) that a regulatory application has been submitted to the U.S. Food and Drug Administration to gain marketing approval for Taxol® (paclitaxel) Injection, administered sequentially to standard combination therapy, for the adjuvant treatment of node-positive breast cancer. Of the more than 180,000 women diagnosed with breast cancer each year in the U.S., approximately 75,500 are candidates for adjuvant therapy. Central to this application are the results of a large adjuvant breast cancer trial led by the Cancer and Leukemia Group B (CALGB) Cooperative Cancer Research Group. The study enrolled more than 3,000 women and is the largest Taxol study ever conducted. The study (CALGB-9344) design was a randomized, phase III clinical trial which compared doxorubicin plus cyclophosphamide alone versus these two drugs followed by Taxol in women with breast cancer that has spread to the lymph nodes. "If approved, this regimen will represent a new standard for patients with breast cancer," said Larry Norton, M.D., head, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center. In the U.S., breast cancer is the second leading cause of cancer-related death in women, after lung cancer. It comprises approximately 30 percent of all female cancer cases and 16 percent of all female cancer deaths. One in eight women will develop breast cancer in her lifetime. In 1960, the risk was one in 14. Improvements, such as adding Taxol to standard adjuvant chemotherapy, have reduced a woman’s risk of developing recurrent breast cancer. "With research advances, women can select among effective, well-tolerated approaches to early-stage breast cancer," commented Amy Langer, Executive Director of the National Alliance of Breast Cancer Organizations (NABCO) and a 14-year breast cancer survivor. "Detecting small breast cancers with mammography that can be treated with powerful new therapies offers great hope. We want women to face, and find -- rather than fear -- breast cancer, and to conquer their disease." "We are very excited by the continued development of Taxol," said Rick Winningham, president, Bristol-Myers Squibb, Oncology/Immunology. "We are hopeful that this advance will enable physicians to better extend the lives of women battling breast cancer." Adjuvant chemotherapy is treatment used very soon after surgery, primarily in early stage disease. In breast cancer, adjuvant chemotherapy is used in addition to surgery with the objective of curing the patient. Adjuvant therapies, including chemotherapy, hormone and radiation therapy, are used either alone or in combination to combat the disease systemically. Other cancer cooperative groups involved in the study were the Eastern Cooperative Oncology Group, the Southwest Oncology Group and the North Central Cancer Treatment Group, which are all sponsored and supported by the National Cancer Institute. In all, several hundred institutions participated. Currently, Taxol is approved as first-line (in combination with cisplatin) and subsequent therapy, for the treatment of advanced carcinoma of the ovary, and for the treatment of breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracyline, unless clinically contraindicated. Taxol is also indicated for use in combination with cisplatin, for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy, and for the second-line treatment of AIDS-Related Kaposi’s Sarcoma. Related Links: Taxol
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