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news.The European Commission has granted full marketing approval to Roche's innovative colorectal cancer drug, Avastin. Roche will now make Avastin available across Europe within the next few weeks.
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Avastin is now approved for the first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with the chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan.
The European Commission’s approval was based on data from a landmark phase III study published in The New England Journal of Medicine in June 2004 that showed patients treated with Avastin plus chemotherapy lived significantly longer than patients receiving chemotherapy alone, on average by nearly five months.
In this study, the addition of Avastin also increased the amount of time that patients were without disease progression, on average four months, compared to patients receiving chemotherapy alone.
Avastin is the first treatment that inhibits angiogenesis – the growth of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (vascular endothelial growth factor), choking off the blood supply essential for the growth of the tumor and its spread throughout the body.
Avastin was approved in February 2004 in the US and has recently received full approval in Switzerland and Israel.
Roche and Genentech are pursuing a comprehensive clinical program investigating the use of Avastin in advanced colorectal cancer with other chemotherapies and also expanding into the adjuvant setting. Roche and Genentech are also investigating the potential clinical benefit of Avastin in other cancers, including non-small cell lung cancer, pancreatic cancer, breast cancer and renal cell carcinoma.