TOKYO--Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; President Osamu Nagayama (hereafter, Chugai)] announced today that bevacizumab (genetical recombination), a humanized anti-VEGF (Vascular Endothelial Growth Factor) monoclonal antibody (brand name: Avastin for intravenous infusion 100mg/4mL or 400mg/16mL) obtained approval today from the Japanese Ministry of Health, Labour and Welfare for the treatment of advanced or refractory colorectal cancer who is not the candidate for the curative operation.

A new drug application for Avastin was filed in April 21, 2006 based on Japanese Phase I study data, along with supporting overseas Phase II and III data, following the recommendation made by the fifth Investigational Committee for Usage of Unapproved Drugs in July 2005.

In Japan, a phase I clinical trial of Avastin combined with 5-FU/l-LV and a Safety Confirmation Study of Avastin combined with FOLFOX4 therapy are conducted, and the pharmacokinetics and tolerability has been confirmed. The approval was granted based on the data of these two domestic studies, as well as overseas studies.

Avastin is a drug with the new mode of action of inhibiting angiogenesis. The conditions for approval were given as: "Because of a very limited number of the subjects treated in the domestic clinical trials, a post-marketing surveillance of all patients who received Avastin after the launch of it should be conducted until the data of a certain number of patients are accumulated in order to identify the background of the patients and collect the safety and efficacy data of them early, and take necessary measures for proper use of Avastin."

Putting the top priority to ensuring the safety of the patients and the implementation of the proper use of Avastin, for a certain time period after launch, the use of Avastin should be limited to the medical institutions which have the sufficient experience in cancer chemotherapy and the ability to provide the effective emergency treatment to the adverse reactions such as gastrointestinal perforations and hemorrhage, and which are willing to cooperate in the post-marketing surveillance involving the registry of every single patient.

Colorectal cancer is one of the most common cancers in Japan, with an estimated 115,000 new patients in 2005. The approval of Avastin in Japan provides a new option in the treatment of colorectal cancer and will contribute to the patients and healthcare professionals via the treatment of the disease. Making the safety of the patients a top priority, Chugai will make every effort to collect and provide information on the proper use of Avastin.