To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Cetuximab Approved in Japan for Treatment of Metastatic Colorectal Cancer URL: http://www.pslgroup.com/dg/225DE2.htm Doctor's Guide July 16, 2008
NEW YORK -- July 16, 2008 -- Marketing authorisation has been granted in Japan for the use of cetuximab (Erbitux) in treating patients with epidermal growth factor receptor (EGFR)-positive, curatively unresectable, advanced or recurrent colorectal cancer (CRC). On the basis of the submitted data, the label allows the use of Erbitux plus irinotecan in second- and further lines of metastatic CRC (mCRC). The Japanese submission was mainly based on data from 6 different studies which included 2 international phase 3 studies -- National Cancer Institute of Canada Clinical Trial Group CO.17 (NCIC CTG CO.17) study and the European Prospective Investigation of Cancer (EPIC) study. The NCIC CTG CO.17 phase 3 study involved 572 patients whose mCRC had progressed with all available standard chemotherapies. The study demonstrated that treating patients with cetuximab as a monotherapy improved overall median survival time by 32% -- 6.1 months with cetuximab compared with 4.6 months with best supportive care alone. The EPIC study involved 1,298 patients with mCRC whose cancer had progressed on first-line treatment with oxaliplatin-based chemotherapy. Patients were treated with either cetuximab plus irinotecan-based chemotherapy or irinotecan-based chemotherapy alone. Overall survival did not differ significantly between the 2 trial arms. However, this may have been because almost half of the patients in the control arm received cetuximab plus irinotecan as post-study treatment after failing irinotecan therapy. Patients in the cetuximab-plus-irinotecan-based chemotherapy arm had significantly longer progression-free survival (4.0 months vs 2.6 months, P < .0001) compared with patients in the irinotecan-based chemotherapy alone arm. Response rates were also higher for patients treated with cetuximab (16.4% vs 4.2%, P < .0001). The most commonly reported side effect with cetuximab is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with cetuximab and about half of these reactions are severe. SOURCE: Merck --------------------------------------------------------------------------------------------- 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.