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| |  FDA Advisory Panel Recommends Expanded Use Of Taxotere For Lung Cancer COLLEGEVILLE, PA -- December 14, 1999 -- Rhone-Poulenc Rorer Inc. (RPR), the global pharmaceutical subsidiary of Rhone-Poulenc S.A., announced that the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) voted to recommend approval of Taxotere(R) (docetaxel) for Injection Concentrate for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of prior chemotherapy.
"Taxotere is the first chemotherapeutic agent to be considered by the FDA for the second-line treatment of advanced non-small-cell lung cancer," said Gary T. Shearman, Ph.D., Senior Vice President, Pharmaceutical Drug Development, and Deputy Head of Research and Development at RPR. "The Committee's favorable opinion is a major step toward making Taxotere available to an underserved lung cancer patient population in the U.S. who have limited treatment options." The favorable opinion of the ODAC was based on the results of two multicenter studies involving over 500 patients, the first Phase III trials ever conducted in advanced NSCLC patients in the second-line setting. "Until now, there have been few treatment options available for patients with advanced non-small-cell lung cancer who do not respond to standard chemotherapy, other than to offer them comfort measures and control their symptoms," said Frank V. Fossella, MD, Medical Director, Thoracic Medical Oncology Multidisciplinary Care Center at The University of Texas, M.D. Anderson Cancer Center in Houston, and primary investigator of one of the studies. "In our trial, we found that patients treated with Taxotere had a significant improvement in survival." In a worldwide Phase III trial presented to the Committee, 204 patients who had previously failed platinum-based chemotherapy received either 75 mg/m2 or 100 mg/m2 of Taxotere every three weeks plus best supportive care (BSC), or BSC alone. BSC refers to measures aimed at maintaining patient comfort, including nutritional support and control of symptoms such as nausea, vomiting, pain and shortness of breath. Patients treated with Taxotere, 75 mg/m2, had a median survival of 7.5 months versus 4.6 months in patients who received BSC. The time to disease progression was 12 weeks and seven weeks in the Taxotere, 75 mg/m2, and BSC groups, respectively. The one-year survival rate was significantly higher in the Taxotere group (37 percent) versus the comparator group (12 percent). Quality-of-life (QOL) for this trial was assessed using two validated tools -- the Lung Cancer Symptom Scale (LCSS) and the European Organization for the Research and Treatment of Cancer (EORTC) QOL questionnaire. The clinical-benefit analysis showed that patients treated with Taxotere, 75 mg/m2, used less radiotherapy and pain-relieving medications and had less weight loss. In the other Phase III study, 373 patients with advanced NSCLC who were resistant to platinum-based chemotherapy received either treatment with Taxotere, 75 mg/m2 or 100 mg/m2, every three weeks, or treatment with either vinorelbine, 30 mg/m2 weekly, or ifosfamide, 2 gm/m2 daily for three days every three weeks. The study, which was carried out at 23 U.S. cancer centers, found that the one-year survival rate in patients treated with 75 mg/m2 of Taxotere was 30 percent, compared to 20 percent in patients treated with either vinorelbine or ifosfamide. The major side effects of Taxotere, 75 mg/m2, in both studies were neutropenia (low blood cell count), fatigue, hypersensitivity and alopecia. Taxotere, a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Taxotere promotes their assembly and blocks their disassembly, thereby preventing cancer cells from dividing and resulting in cancer cell death. Recently, the Committee for Proprietary Medicinal Products (CPMP) recommended approval for Taxotere in the 15 Member States of the European Union for the treatment of patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy. It is presently approved for the treatment of advanced NSCLC in more than 40 other countries. Taxotere was first approved in the U.S. in 1996 for the treatment of advanced breast cancer after failure of anthracycline-based therapy. Taxotere is now approved in more than 80 countries, including the U.S. and the European Union, for the treatment of advanced breast cancer after failure of prior chemotherapy. In patients with normal liver function, side effects reported to date include neutropenia, thrombocytopenia (low platelet count), anemia, fluid retention, hypersensitivity, nausea and diarrhea. A premedication regimen with corticosteroids is recommended in order to prevent or reduce hypersensitivity and fluid retention. Taxotere is generally not appropriate therapy for patients with liver impairment. Attributed primarily to smoking and tobacco use, lung cancer is the number-one cause of cancer-related deaths in the U.S., killing more men and women each year than breast, prostate and colorectal cancers combined. Lung cancer has now surpassed even breast cancer as the number-one cancer killer of women. In addition, lung cancer is the second most commonly diagnosed cancer in the U.S. Each year, an estimated 171,500 Americans will be diagnosed with lung cancer and approximately 160,000 people will die of the disease. Deaths from lung cancer account for 28 percent of all cancer deaths. Non-small-cell lung cancer is the more common of the two types of lung cancer, accounting for 75 percent of all cases. At present, patients with advanced NSCLC have relatively limited treatment options. Only 25 percent of patients have tumors that are operable. The majority of patients are treated with radiation therapy and/or chemotherapy, and best supportive care.
Related Links: Taxotere (docetaxel) and Rhone-Poulenc Rorer Inc.
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