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European Commission continues to support Avastin in combination with paclitaxel as an effective treatment option for women with metastatic breast cancer

9 March 2011 298 No Comment

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission confirmed that Avastin (bevacizumab) in combination with paclitaxel will remain a treatment option for women with metastatic breast cancer in Europe. The decision follows recent recommendations made by the Committee for Medicinal Products for Human Use (CHMP) that Avastin in combination with paclitaxel has been convincingly shown to enable women with metastatic breast cancer to live longer without their disease getting worse (progression-free survival) and that the combination is a valuable treatment option.

“We are pleased that the European Commission is continuing to support Avastin in combination with paclitaxel,” said Hal Barron M.D., Chief Medical Officer and Head, Global Product Development. “This is important news for thousands of women living with incurable HER2-negative breast cancer in the European Union.”

Paclitaxel is the chemotherapy most frequently used in Europe and also most frequently partnered with Avastin for the first-line treatment of metastatic breast cancer. The Commission also followed a CHMP recommendation to remove the combination of Avastin with docetaxel for the first-line treatment of metastatic breast cancer from the label.

The updated label is effective immediately. The changes to the European breast cancer label do not affect the other approved uses of Avastin across several types of cancer.
About Avastin: Over 5 Years of Transforming Cancer Care

With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in the US and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer and kidney cancer, and Avastin is also available in the US and over 31 other countries for the treatment of patients with glioblastoma (a type of brain cancer). Avastin is the only anti-angiogenic therapy available for the treatment of these numerous advanced cancer types, which collectively cause over 2.5 million deaths each year.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today – over three quarters of a million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of Avastin in over 50 tumor types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian and others) and different settings (advanced or early stage disease).
About Avastin: Mode of Action

Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumor angiogenesis – a fundamental process required for a tumor to grow and to spread (metastasise) to other parts of the body. Avastin’s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Avastin helps to control tumor growth and extend survival with only a limited impact on the side effects of chemotherapy.
About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

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