Positive recommendation for Avastin use in advanced or recurrent colorectal cancer in Japan

Priority review process aims to make Avastin available to patients as soon as possible

BASEL, Switzerland | Feb 26, 2007 |
Roche today 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/or 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 1,2,3

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 world’s first angiogenesis inhibitor was approved by the FDA 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.

Data used for filing
The local Phase I study was conducted in 18 patients with metastatic carcinoma of the colon or rectum to investigate the pharmacokinetics and safety of Avastin in Japanese patients when used in combination with 5-fluorouracil/folinic acid.

A Phase II study (AVF2192) demonstrated that Avastin, when added to a combination of 5-fluorouracil/folinic acid, prolonged the time until disease progression or death by an extra four months compared to chemotherapy alone (a 67% increase in progression-free survival).

In the Phase III pivotal trial (AVF2107), patients with previously untreated metastatic carcinoma of the colon or rectum (mCRC) who received Avastin in combination with intravenous 5-fluorouracil/folinic acid/irinotecan lived significantly longer than patients receiving the same chemotherapy without Avastin- on average by nearly five months (20.3 months versus 15.6 months). Also, the addition of Avastin increased the amount of time that patients were without disease progression, on average four months, compared to patients receiving chemotherapy alone (10.6 months versus 6.2 months).

In a second Phase III study (E3200), conducted by the Eastern Cooperative Oncology Group (ECOG), Avastin was also shown to significantly improve survival when added to another widely prescribed chemotherapy regimen (oxaliplatin/5-fluorouracil/leucovorin). With Avastin, patients who had failed previous irinotecan or 5-FU containing chemotherapy for their disease, lived nearly two months longer, on average, compared to those who received chemotherapy alone (12.9 months vs. 10.8 months).

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 a supplier of innovative 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 a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. 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 people in 150 countries 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 www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Additional information:
- Chugai Pharmaceutical Co.
- Roche in Oncology
- Roche Health Kiosk on cancer
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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) 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.
5) A.Oshima, T.Kuroishi, K.Tajima, Cancer White Paper -Incidence/Death/Progonosis - 2004


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