Roche: Chugai Wins Backing For Avastin In Colorectal Cancer

Asian Wall Street Journal (02/26/07)

Swiss drugmaker Roche Holding AG reports Chugai Pharmaceutical Co Ltd, in which it holds a majority, has won backing by the Japanese regulator for Avastin use in advanced or recurrent colorectal cancer. The recommendation was granted by a consultative expert panel for the Japanese Ministry of Health, Labour and Welfare. The approval is expected by mid-year. Chugai had submitted a New Drug Application for Avastin in April 2006. This process enables faster submission of certain medicines with proven efficacy which are approved in the US and/or Europe but are not yet available in Japan. The Avastin filing was based on local Phase I data, along with supporting US and European Phase II and pivotal Phase III data. In Japan, the incidence of colorectal cancer has increased significantly in the last 50 years and research interest in this cancer has grown rapidly among Japanese clinicians and pathologists. In 2005, colorectal cancer was one of the most commonly reported cancer with an estimated incidence of 115,000 people in Japan. Avastin is the first and only anti-angiogenic agent which has been shown to consistently deliver improved overall and/or progression-free survival benefit for colorectal, lung, breast, and renal cell cancer patients. (Click here for more - May Require Paid Subscription)