To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Nexavar for Treatment of Liver Cancer URL: http://www.pslgroup.com/dg/21785E.htm Doctor's Guide November 19, 2007
LEVERKUSEN, GERMANY -- November 19, 2007 -- The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for Nexavar (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC). Nexavar, an oral anti-cancer drug, is the first approved systemic drug therapy for liver cancer and the only drug therapy shown to significantly improve overall survival in patients with the disease. In Europe, Nexavar was approved for the treatment of HCC in October of this year. In 2005, Nexavar became the first new treatment in more than a decade for advanced kidney cancer and is currently approved in more than 60 countries for this indication. HCC, the most common form of liver cancer, is responsible for about 90% of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year (about 19,000 in the U.S., 54,000 in Europe, and 390,000 in China, Korea and Japan) and incidence is increasing. "The American Liver Foundation (ALF) is always pleased when new therapies prove effective for those affected by liver disease. Researchers worldwide, including those supported by ALF, have spent decades studying liver cancer," said James L. Boyer, MD, chairman, board of directors, American Liver Foundation. "This new treatment provides a valuable option for liver cancer patients and will enable ALF to further promote the treatment of liver disease through our education and advocacy efforts." The FDA approval was based on positive data from the international, phase 3, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial, which demonstrated that Nexavar improved overall survival by 44% in patients with HCC (HR=0.69; P =.0006) versus placebo. Median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo. No indication of imbalances was observed in serious adverse event rates between the Nexavar- and placebo-treated groups, with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. SOURCE: Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. --------------------------------------------------------------------------------------------- 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.