Breakthrough cancer drug Avastin approved in Japan for use in advanced or recurrent colorectal cancer

Chugai, a member of the Roche Group, announced that marketing approval has been granted for the use of the breakthrough cancer drug Avastin (bevacizumab) in patients with inoperable advanced or recurrent colorectal cancer in Japan.

The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted this approval following the recommendation made in July 2005 by the Investigational Committee for Usage of Unapproved Drugs that an early filing be made for Avastin. 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.

“Today’s approval represents a significant milestone for doctors and patients in Japan, especially given the high incidence of colorectal cancer in this country.” said Williams M. Burns, CEO Division Roche Pharmaceuticals “We will now work to ensure that Avastin is made available to Japanese patients suffering from colorectal cancer as quickly as possible.”

This approval is based on Japanese Phase I and Safety Confirmation Study data, along with supporting US and European Phase II and pivotal Phase III data which demonstrated Avastin’s improvement of overall and/or progression-free survival in metastatic colorectal cancer.1,2,3,4

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 pathologists5. In 2005, colorectal cancer was one of the most commonly reported cancer with an estimated incidence of 115,000 people in Japan6.

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. In October 2006, following priority review, the world’s first angiogenesis inhibitor was approved by the FDA for the treatment of non-small cell lung cancer (NSCLC); a filing for the same indication was submitted to EU authorities in August 2006. Most recently in April 2007, Avastin was approved in Europe for the first line treatment of women with metastatic breast cancer.