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European Commission Approves Bevacizumab for First-Line Use in Women With Metastatic Breast Cancer

March 29, 2007 -- Roche today announced that their innovative cancer drug Avastin (bevacizumab) has been approved in Europe for the treatment of women with metastatic breast cancer.

The European Commission has approved Avastin for the first line treatment of women with metastatic breast cancer in combination with a standard chemotherapy paclitaxel (originally branded Taxol). The approval is based on pivotal Phase III trial data (E2100) which show that women with metastatic breast cancer have the chance to live twice as long without their cancer progressing if treated with Avastin plus paclitaxel compared to paclitaxel alone.

"Today’s approval represents a significant advancement in breast cancer therapy,"said William M. Burns, CEO Division Roche Pharmaceuticals. "We are proud to launch this significant new treatment option. We will now work to ensure that Avastin is being made widely available to European physicians and patients with metastatic breast cancer as quickly as possible."

David Cameron, medical oncologist, Lothian University Hospitals NHS Trust and Clinical Lead for the South East Scotland Cancer Research Network, welcomed the news: "It is devastating for a woman to be diagnosed with advanced breast cancer. Despite all the improvements in treatment that have already been made, the remarkable effect of Avastin in prolonging the time to progression of metastatic breast cancer will be welcomed by patients - this time gained is very precious."

Each year more than one million new cases of breast cancer are diagnosed worldwide, resulting in over 400,000 deaths per year. Metastatic breast cancer is the number one cause of cancer death worldwide in women under the age of 551.

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.

Additional phase III trials are ongoing to explore Avastin in the first line treatment of metastatic breast cancer in combination with docetaxel (AVADO) and other commonly used chemotherapies including Xeloda (RIBBON-1). Recently, a phase III 1st line trial (AVEREL) in HER2-positive breast cancer evaluating Avastin in combination with docetaxel plus Herceptin was initiated.

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 advanced colorectal cancer. 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. Most recently (in February 2007), a positive recommendation was received in Japan for the use of Avastin in patients with advanced or recurrent colorectal cancer.

About the E2100 study
Study E2100 was the first Phase III study set to evaluate Avastin in combination with paclitaxel versus paclitaxel alone for the first-line treatment of patients with locally recurrent or metastatic breast cancer. This randomised, controlled, multi-centre study enrolled 722 women. The study was sponsored by the National Cancer Institute (NCI), part of the 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. The trial was designed to give Avastin 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 more than a year (13.3 months) while patients receiving paclitaxel alone had a median PFS of approximately 7 (6.7 months) months. PFS is a measure of the time patients live without their disease progressing. 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 PFS (1/0.48= ~2). Roche will submit OS data analysis during 2007 to EU regulatory authorities based on the all randomized patient population with a still to be defined cut-off date.

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.

Source: Roche

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