To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Caelyx (Pegylated Liposomal Doxorubicin Hydrochloride) Approved In Europe For Advanced Ovarian Cancer URL: http://www.pslgroup.com/dg/1E81EE.htm Doctor's Guide October 26, 2000
KENILWORTH, NJ -- October 26, 2000 -- Schering-Plough Corporation announced that the European Union's (EU) Commission of the European Communities has granted marketing authorization to Caelyx® (pegylated liposomal doxorubicin hydrochloride) for the treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. The pivotal clinical study on which the marketing authorization is based demonstrated clear advantages of Caelyx over topotecan, the standard approved agent for this indication. The authorization recommends Caelyx be administered intravenously at a dose of 50 mg/m2 once every four weeks for as long as the disease does not progress and the patient continues to tolerate treatment. Commission approval of the centralized Type II variation for Caelyx results in a single Marketing Authorization with unified labeling that is immediately valid in all 15 EU-Member States. The Commission's decision follows the product's recommendation for approval in June 2000 by the EU's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA). Caelyx has previously received centralized marketing authorization in the EU and is currently marketed for the treatment of AIDS-related Kaposi's sarcoma in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. "The approval of Caelyx in Europe for advanced ovarian cancer provides a valuable addition to the therapies available to physicians for treating this devastating disease," said Thomas C. Lauda, executive vice president, global marketing, Schering-Plough Pharmaceuticals. "The product's safety profile and convenient once-a-month dosing regimen may enhance patients' ability to maintain a more normal lifestyle during treatment." Caelyx is a long-circulating STEALTH® pegylated liposomal formulation of doxorubicin hydrochloride, a widely used cytotoxic agent. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumors. Schering-Plough has exclusive international marketing rights to Caelyx, excluding Japan and Israel, through a distribution agreement with ALZA Corporation of Mountain View, Calif. ALZA markets the product in the United States under the tradename Doxil®. Ovarian cancer is the second most common gynecologic cancer and causes more deaths than any other cancer of the female reproductive system. Despite improvements in both response rates and survival with current combination chemotherapies, up to 30 percent of patients fail to respond to first-line therapy with platinum and paclitaxel. In addition, 55 percent to 75 percent of responding patients will relapse within two years. Because ovarian cancer has few early symptoms, most patients are not diagnosed until after their disease has progressed to an advanced stage, which contributes to the high mortality rate. Related Link: Schering-Plough Corporation. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.