EC expands indication for Roche's Avastin

8 April 2007

The European Commission has approved Swiss drug major Roche's Avastin (bevacizumab) for the first line treatment of women with metastatic breast cancer in combination with the standard chemotherapy paclitaxel. The approval is based on pivotal 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 plus paclitaxel compared to paclitaxel alone.

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 55. David Cameron, medical oncologist, clinical lead for the South East Scotland Cancer Research Network, welcomed the news, saying: "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."

According to Roche, 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 and other commonly-used chemotherapies including Xeloda (capecitabine).

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