Avastin gets tentative clearance in Japan

Swiss drug major Roche says that its Japanese subsidiary Chugai has received a positive recommendation for the use of Avastin (bevacizumab) in patients with advanced or recurrent colorectal cancer by a consultative expert panel for the Japanese Ministry of Health, Labour and Welfare (MHLW). The drug's approval is expected by the middle of the year.

The Investigational Committee for Usage of Unapproved Drugs, a body established by the MHLW, 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 USA 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 trial findings. In Japan, the incidence of colorectal cancer has increased significantly in the last 50 years and, by 2005, this was one of the most commonly reported cancers with an estimated incidence of 115,000 people in Japan.