Roche announced that Chugai has received a positive recommendation for the use of Avastin (bevacizumab) in patients with advanced or recurrent colorectal cancer. This recommendation was granted by a consultative expert panel for the Japanese Ministry of Health, Labour and Welfare (MHLW). The approval is expected by mid-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 (NDA) 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.
"Today's decision represents a further significant milestone for oncologists and patients 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 M Burns, CEO Division Roche Pharmaceuticals "We are looking forward to making this groundbreaking treatment available to colorectal cancer patients in Japan as quickly as possible."
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 4. In 2005, colorectal cancer was one of the most commonly reported cancer with an estimated incidence of 115,000 people in Japan 5.
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.
In Europe, Avastin was approved in January 2005 and in the US in February 2004 for first-line treatment of patients with metastatic colorectal cancer. It received another approval in the US in June 2006 as a second-line treatment for patients with metastatic colorectal cancer. The first filing for Avastin in Japan occurred in April 2006 for the treatment of advanced or recurrent colorectal cancer. Most recently following priority review, the FDA approved the world's first angiogenesis inhibitor in October 2006 for the treatment of non-small cell lung cancer (NSCLC); a filing for the same indication was submitted to EU authorities in August 2006.