This recommendation was granted by the Japanese Ministry of Health, Labour and Welfare and the approval is expected by mid-year.
It was recommended that an early filing be made for Avastin. Accordingly, Chugai submitted a new drug application in April 2006. This process enables faster submission of certain medicines with proven efficacy which are approved in the US and Europe but are not yet available in Japan.
“The Japanese authorities have recognized that Avastin is a breakthrough drug which addresses an unmet medical need for patients suffering with advanced colorectal cancer,” said Williams Burns, CEO Division Roche Pharmaceuticals.
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.
The Avastin filing was based on local phase I data, along with supporting US and European phase II and phase III data. Avastin is the 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.