Avastin receives positive opinion in Europe for first-line treatment of women with metastatic breast cancer

Breakthrough therapy offers women the chance to live twice as long without their cancer progressing

BASEL, Switzerland | Feb 23, 2007 |
Roche announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the use of its cancer drug Avastin in combination with a standard chemotherapy paclitaxel (originally branded Taxol) in previously untreated metastatic breast cancer. The CHMP’s decision is based on Phase III trial data which show that women with metastatic breast cancer have the chance to live twice as long without their cancer progressing if treated with Avastin in addition to paclitaxel compared to paclitaxel alone. This is the first Phase III study involving an anti-angiogenic agent to report positive outcome for patients with metastatic breast cancer.

"This decision represents a significant milestone, bringing breast cancer patients and the medical community one step closer to broadly accessing a highly effective new cancer therapy in Europe", says Williams M. Burns, CEO Division Roche Pharmaceuticals. "Avastin has shown excellent progression-free survival data in treating this disease and after approval two years ago for first line treatment of metastatic colorectal cancer, this decision also confirms that Avastin has the potential to become part of the treatment armamentarium for a whole range of tumour types."

Eight to nine percent of women will develop breast cancer during their lifetime, making it the most common type of cancer in women.1 Each year more than one million new cases of breast cancer are diagnosed worldwide, with a death rate of nearly 400,000 people per year.
Metastatic breast cancer is the number one cause of cancer death worldwide in women under the age of 552.

Additional phase III trials are ongoing to explore Avastin in the first line treatment of metastatic breast cancer in combination with the chemotherapy Taxotere (docetaxel) and other commonly used chemotherapies including Xeloda. Recently, a phase III trial in HER2-positive patients evaluating Avastin in combination with Herceptin and docetaxel was also initiated.

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 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.

About the E2100 study
This is the first Phase III study to evaluate Avastin in combination with paclitaxel for first-line treatment of patients with locally recurrent or metastatic breast cancer. This randomised, controlled, multi-centre study enrolled 722 women with previously untreated locally recurrent or metastatic breast cancer. The study was sponsored by the National Cancer Institute (NCI), part of the US National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). The patients were randomised to receive treatment with paclitaxel with or without Avastin. Avastin was given at a dose of 10mg/kg every two weeks until disease progression. The results showed that patients receiving Avastin plus paclitaxel had a median progression-free survival (PFS) of 13.3 months while patients receiving paclitaxel alone had a median PFS of 6.7 months months. PFS is a measure of the time patients live without their disease progressing or dying due to any cause. Overall in the trial, patients treated with Avastin plus paclitaxel had a 52 percent reduction in the risk of disease progression or death, as expressed by a hazard ratio of 0.48 (1-0.48=0.52 or 52%), which is also identical to doubling of PFS (1/0.48= ~2).Overall survival data should become available during 2007.

Overall, in the E2100 study, Avastin in combination with paclitaxel was generally well tolerated and had a favourable safety profile in patients with locally recurrent or metastatic breast cancer at the recommended dose of 10 mg/kg every two weeks.

About Avastin
Avastin is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).

Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma, prostate and others) and different settings (advanced and adjuvant ie post-operation). The total development programme is expected to include over 40,000 patients worldwide

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.


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