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Roche files marketing application for Avastin with European health authorities

Roche today announced the submission of a Marketing Authorisation application to the European Union for Avastin (bevacizumab, rhuMAb-VEGF) as a treatment for first-line metastatic colorectal cancer in combination with chemotherapy. The application is based on data from a pivotal clinical study of over 900 patients on Avastin who experienced improved survival benefit compared to chemotherapy treatment alone. A safety database of more than 1,000 patients who received Avastin in clinical trials is also supporting the submission.

In 2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide. It is estimated that over 50% of people diagnosed with colorectal cancer will die, and it is the most common cancer in developed countries.1

"We are delighted to announce the submission for marketing authorisation of Avastin in the European Union," said William M. Burns, Head of Roche Pharmaceuticals Division. "Roche is dedicated to the development of safe and efficacious treatments for many types of cancers, and we will work closely with regulatory authorities to bring Avastin to patients as quickly as possible, particularly as this is the first treatment of its kind."

An application for approval of Avastin in metastatic colorectal cancer was filed with the US FDA in September and has been designated for priority review status.

Results of the pivotal study of Avastin in advanced colorectal cancer were announced earlier this year and demonstrated that Avastin plus a form of chemotherapy, the IFL regime, (5-FU/Leucovorin/CPT-11) improved median survival by approximately five months, compared to patients treated with IFL regime alone (20.3 months vs. 15.6 months).

Avastin is the first anti-cancer agent with proven efficacy in inhibiting vascular endothelial growth factor (VEGF), which suppresses tumour growth and the spread of cancer from one part of the body to another (metastasis).
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Contact: Elizabeth Park, Resolute Communications
elizabeth.park@resolutecommunications.com
44-207-357-8187
Resolute Communications
5-Dec-2003


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