Filing for new European registration based on largest-ever TAXOL clinical trial. Bristol-Myers Squibb Company (NYSE: BMY) announced today that an application for European marketing authorization has been submitted to the Dutch Health Authorities for the use of TAXOL(R) (paclitaxel) for the adjuvant treatment of node-positive breast cancer. Of the more than 250,000 women diagnosed with breast cancer each year in the E.U., approximately 102,500 are candidates for adjuvant therapy. The Dutch Health Authorities are central to the regulatory review of TAXOL in the European Union. Submissions to the other 14 E.U. member states are now ongoing. The European filing closely follows a supplemental New Drug Application for the same indication, which was submitted to U.S. FDA in April of this year. Central to the U.S. and European applications are the results of a major Phase III adjuvant breast cancer trial led by the Cancer and Leukemia Group B (CALGB) Cooperative Cancer Research Group, a leading clinical research organization in the U.S. sponsored by the National Cancer Institute. The study (CALGB- 9344) is the largest TAXOL study ever conducted. It enrolled more than 3,000 women whose breast cancer spread to the lymph nodes. These patients were randomized to receive either the standard adjuvant treatment combination -- doxorubicin plus cyclophosphamide -- or doxorubicin plus cyclophosphamide, followed by TAXOL. Results of a planned interim analysis of this trial have shown that the sequential addition of TAXOL to the standard combination reduces risk of death by 26 percent and reduces the risk of cancer recurrence by 22 percent. Trial results have been updated with a 30-month analysis, also included in the U.S. and European regulatory filings. "The interim analysis of CALGB-9344 represents the single most significant advance in the treatment of early-stage breast cancer in the past 20 years since the introduction of doxorubicin," said Richard L. Schilsky, M.D., director, University of Chicago Cancer Research Center; professor of medicine, University of Chicago and chairman, CALGB. "This new combination has the potential to save tens of thousands of lives worldwide each year." "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 and Chair of the CALGB's breast committee. Dr. Norton emphasized that experience from other landmark breast cancer adjuvant trials suggests that the early benefit defined by CALGB- 9344 will be maintained with continued follow-up. Other U.S. 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. Breast cancer is the most common cancer in women and the leading cause of female cancer death in the E.U. Currently, one in 10 European women have a lifetime risk of developing breast cancer. Improvements in early detection and treatment have driven reductions in mortality in some countries, and they remain a major focus of the breast cancer research community. Experts recently have emphasized that the rapid development of better adjuvant chemotherapy regimens is a short-term priority for improved breast cancer outcomes throughout Europe(1). "Widespread availability of TAXOL for the adjuvant treatment of breast cancer will give European physicians and patients a powerful new tool to combat disease and increase chance of cure," said Professor David Khayat, Head, Department of Medical Oncology, Salpetriere Hospital, Paris, who provided the expert report for the European filing. "If we can decrease risk of death by 26 percent in the large European patient population eligible for adjuvant therapy, the implications will be staggering." "As promising new adjuvant regimens are developed, it becomes even more crucial that women throughout Europe better understand the importance of breast awareness, screening and early detection," said Gloria Freilich, President of Europa Donna, a pan-European breast cancer patient advocacy organization. "The combination of early detection and widespread access to clinically proven, powerful new therapies will mean that more women with breast cancer will survive this disease than ever before." 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. 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. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer medicines, beauty care, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders and cancer. The world leader in oncology, Bristol-Myers Squibb is deeply committed to cancer research, clinical development and patient care. (1) Significant Promise of Adjuvant Therapy Requires Clinical Trial Commitment; official communication of the First European Breast Cancer Conference, October 2 1998.
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