To: 5,17,37,5,101,... who wrote (596 ) 3/23/1998 7:37:00 PM From: flickerful Read Replies (1) | Respond to of 756
jackson... what about those terms, and this news: Friday March 20, 5:18 pm Eastern Time Company Press Release SOURCE: Bristol-Myers Squibb Oncologic Drugs Advisory Committee Recommends TAXOL(R) for First-Line Use in Non-Small-Cell Lung Cancer PRINCETON, N.J., March 20 /PRNewswire/ -- The Oncologic Drugs Advisory Committee (ODAC) today recommended that the U.S. Food and Drug Administration approve TAXOL(R) (paclitaxel) Injection in combination with cisplatin for the first-line treatment of non-small-cell lung cancer (NSCLC). This recommendation was based on data gathered from studies involving more than 3,000 patients and is one of the largest Supplemental New Drug Applications (sNDA) that has ever been submitted for approval of a drug for the treatment of NSCLC. ''These data confirm that TAXOL, when combined with a platinum agent, results in higher response rates and increased survival and quality of life benefits compared to standard cisplatin-based combination regimens,'' said Paul A. Bunn, M.D., Director of the University of Colorado Cancer Center, Denver, a specialist in lung cancer and former chairman of the Oncologic Drugs Advisory Committee. ''TAXOL-based regimens represent an important advance in the treatment of NSCLC. Patients and their families should be aware that chemotherapy for lung cancer can potentially improve cure rates in some cases.'' Pivotal data presented in the sNDA were gathered from three large, randomized, phase III clinical studies comparing TAXOL plus a platinum agent to standard therapies. The three trials demonstrate that TAXOL/platinum-based chemotherapy is generally well-tolerated and effective in the treatment of NSCLC. The studies showed overall clinical benefit such as improved response rates, increased time to disease progression, symptom alleviation, quality of life and safety, with survival as good as or better than the standard regimen. These trials were conducted by renowned global cooperative groups, including the Eastern Cooperative Oncology Group in the U.S. and the European Organization for the Research and Treatment of Cancer. Approximately 178,000 Americans were diagnosed in 1997 with lung cancer, the leading cause of cancer deaths in the United States, according to the American Cancer Society. NSCLC constitutes approximately 80 percent of lung cancer cases. It is estimated that among those patients with NSCLC, 70,000 are eligible for chemotherapy but do not receive it. Administration of chemotherapy to patients with advanced lung cancer has demonstrated an increase in survival rates and significant improvement in patients' quality of life. The enormous database of clinical experience with the combination of TAXOL plus a platinum agent in this setting has led the major oncology cooperative groups worldwide to adopt this regimen as the standard of care in the treatment of NSCLC. Additionally, based on the clinical benefit derived in late stage disease, regimens of TAXOL plus a platinum agent are being combined with radiation therapy in earlier disease stages with very encouraging preliminary results. ''Promising new studies indicate that TAXOL-based regimens provide increased clinical benefits when used in combination with radiation in earlier stages of disease,'' said Renzo Canetta, M.D., Vice President, Clinical Oncology, Bristol-Myers Squibb. ''Preliminary results suggest that TAXOL will significantly improve the way lung cancer is currently treated -- offering patients an option that can improve quality of life and could potentially increase survival rates.'' ''TAXOL has demonstrated clinically significant improvements in survival in a number of disease settings,'' said Rick Winningham, President, Bristol-Myers Squibb Oncology/Immunology. ''Bristol-Myers Squibb remains committed to continuing to develop TAXOL to its full therapeutic potential. TAXOL is one of the most widely researched anticancer drugs. It is being studied in more than 500 clinical trials enrolling more than 25,000 patients globally.'' TAXOL is indicated in the U.S. for second-line treatment of breast and ovarian cancers and for the second-line treatment of AIDS-related Kaposi's sarcoma. The most common side effects associated with TAXOL are reduction in white blood cell count, known as myelosuppression, and hair loss. Numbness in the extremities (peripheral neuropathy), muscle or bone pain (myalgia/arthralgia) and nausea also may occur. Other side effects are listed in the package insert. Of note, no new side effects have occurred when TAXOL is used in combination with a platinum drug. Bristol-Myers Squibb (NYSE: BMY - news) is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, 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 company is a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. The Oncologic Drugs Advisory Committee is an external panel of experts that provides independent scientific advice to the Agency in its evaluation of oncology products. Although the committee's recommendation is non-binding, it will be considered by the FDA in the Agency's review of the Supplemental New Drug Application for TAXOL in the first-line treatment of non-small-cell lung cancer. Visit Bristol-Myers Squibb on the World Wide Web at: bms.com SOURCE: Bristol-Myers Squibb