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.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at roche.

References

1. Hurwitz, H, Fehrenbacher, L, Novotny, W, et al. Bevacizumab plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer. New England Journal of Medicine 2004; 350(23): 2335??"2342

2. Kabbinavar FF, Joseph Schulz J, McCleod M, et al. Addition of Bevacizumab to Bolus 5-FU/Leucovorin in First-Line Metastatic Colorectal Cancer: Results of a Randomized Phase II Trial.) J Clin Oncol 23:10.1200/JCO.2005.05.112, 2005

3. Mitchell EP, Alberts SR, Schwartz BJ, et al. High-dose bevacizumab in combination with FOLFOX4 improves survival in patients with previously treated advanced colorectal cancer: Results from the Eastern Cooperative Oncology Group (ECOG) study E3200. ASCO Gastrointestinal 2005 Cancer Symposium, January 2005 (abstract 169a)

4. Cassidy J, et al. Annal Oncol 2006;17(Suppl 9)

5. Koyame Y, Kotake K. Overview of colorectal cancer in Japan: report from the Registry of the Japanese Society for Cancer of the Colon and Rectum.; Dis Colon Rectum 1997, Oct, 40 (10 Suppl): S2-9.

6. A.Oshima, T.Kuroishi, K.Tajima, Cancer White Paper -Incidence/Death/Progonosis - 2004

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