CPMP Recommends Approval of Taxotere(R) to Treat Advanced Non-Small-Cell Lung Cancer in the European Union

COLLEGEVILLE, Pa., and ANTONY, France (PROTEXT) - Rhone- Poulenc Rorer (RPR), the global pharmaceutical subsidiary of Rhone-Poulenc S.A. (NYSE: RP), announced that the Committee for Proprietary Medicinal Products (CPMP) recommended approval of Taxotere(R) (docetaxel) in the 15 Member States of the European Union* for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of prior chemotherapy. The CPMP is the scientific committee of the European Agency for the Evaluation of Medicinal Products (EMEA). This favorable CPMP opinion now has to be endorsed by the European Commission before Taxotere receives final marketing authorization in this indication. Up to now, Taxotere was approved in the European Union for the treatment of locally advanced or metastatic breast cancer after failure of prior chemotherapy, including an anthracycline or an alkylating agent. "The clinical trial data we presented clearly led to the Committee's favorable opinion for the use of Taxotere in the European Union to treat 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. "This is a major step toward making Taxotere available to an underserved patient population with few treatment options." The favorable opinion of the CPMP was based on the results of two Phase III, multicenter studies involving patients with advanced non-small-cell lung cancer whose disease had progressed on prior chemotherapy. In a pivotal Phase III trial, 204 patients whose disease had failed to respond to platinum-based chemotherapy received either 75 mg/m2 or 100 mg/m2 of Taxotere given as a one-hour infusion on day one and repeated every three weeks, or best supportive care (BSC). 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. In patients treated with Taxotere at 75 mg/m2, overall survival (median is 9 months versus 4.6 months) and time to progression (median is 12.3 weeks versus 7 weeks) were significantly longer compared to patients receiving BSC. The one- year survival rate was also significantly longer, in patients treated with Taxotere at 75 mg/m2 (40 percent) versus BSC (16 percent). "Historically, patients with recurrent or resistant non-small- cell lung cancer are a very challenging population with a poor survival rate," said Francis Shepherd, MD, Professor of Medicine at the University of Toronto, and the Princess Margaret Hospital, Toronto, Ontario, Canada, and primary investigator of the trial. "We are greatly encouraged by the results we have seen with Taxotere." Patient quality-of-life (QOL) was assessed using several tools, including the Lung Cancer Symptom Scale (LCSS) and the European Organization for the Research and Treatment of Cancer (EORTC) QOL questionnaire. The analysis showed that patients treated with Taxotere used less radiotherapy and symptom- relieving medications and had less weight loss. The QOL evaluation also showed that patients treated with Taxotere had less pain and fatigue and more appetite. In the second multicenter Phase III trial, 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 found that the one-year survival rate in patients treated with 75 mg/m2 of Taxotere was 32%, compared to 19% in patients treated with either vinorelbine or ifosfamide. About Taxotere Taxotere, a drug in the taxane 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, which results in cancer cell death. Common side effects associated with Taxotere may include low blood cell counts, 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 not an appropriate therapy for some patients with severe liver impairment. To date, Taxotere is approved for the treatment of advanced NSCLC in more than 40 other countries. Taxotere also is approved in more than 80 countries, including the European Union and the United States, to treat advanced breast cancer after failure of prior chemotherapy. Taxotere is not yet approved in the United States for the treatment of non-small-cell lung cancer. About Lung Cancer Attributed primarily to smoking and tobacco use, lung cancer is the second leading cause of cancer-related deaths worldwide. Although the incidence of lung cancer in men has leveled off, the incidence in women continues to increase. Among women, lung cancer now exceeds breast cancer as the number one cause of cancer-related deaths. Non-small-cell lung cancer is the most common type of lung cancer, accounting for 80 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. Rhone-Poulenc Rorer is a global pharmaceutical company dedicated to improving human health. Rhone-Poulenc S.A. (NYSE: RP), is a leading life sciences company, growing through innovations in human, plant and animal health. With sales in 1998 of FF86.8 billion (U.S. $14.8 billion; Euros 13.2 billion), Rhone-Poulenc employs 65,000 people in 160 countries worldwide. The RPR Internet website is at http://www.rp-rorer.com. *Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden and the United Kingdom. NOTE: The "2" in "75 mg/m2", "100 mg/m2", "30 mg/m2" and "2 gm/m2" is superscript. ots Original Text Service: Rhone-Poulenc Rorer Internet: http://www.newsaktuell.de Contact: Terri Pedone of Rhone-Poulenc Rorer (US), 610-454-8284, or Sophie Langlois of Rhone-Poulenc Rorer (France), 33 1 55 71 72 63 Web site: http://www.rp-rorer.com Subscribers please note that material bearing the slug "PROTEXT" is not part of CTK's news service and is not to be published under the "CTK" slug. Protext is a commercial service providing distribution of press releases from clients, who are identified in the text of Protext reports and who bear full responsibility for their contents. PROTEXT