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Trial results further prove Avastin breast cancer benefits

New clinical trial results have confirmed the benefit that Roche and Genentech's drug Avastin (bevacizumab) can have in breast cancer.

New clinical trial results have confirmed the benefit that Roche and Genentech's drug Avastin (bevacizumab) can have in breast cancer.

The drug is already approved for the treatment of colorectal and lung cancer.

A phase III study in metastatic breast cancer investigating Avastin (bevacizumab) in combination with docetaxel chemotherapy compared to docetaxel alone, met its primary endpoint of improving the time patients live without their disease advancing.

This is good news for Roche, which is hoping to get the drug approved as a breast cancer treatment. The US Food and Drug Administration (FDA) is due to make its decision on February 23.

An earlier study found that the Avastin slowed the progression of breast cancer, but didn't actually extend the lives of the women who took the drug. Based largely on that study, an FDA advisory committee voted 5-4 against approving Avastin for breast cancer in late 2007.

Researchers from FBR research are not convinced that the new data will sway the FDA. Researchers from Credit Suisse echoed this sentiment, stating there was a lack of overall survival data.

EU approval

This second positive phase III trial follows the recently published landmark E2100 study, which formed the basis of European Commission approval of Avastin in combination with paclitaxel for the first line treatment of metastatic breast cancer in March 2007. Study E2100 showed that the addition of Avastin to paclitaxel resulted in a doubling of progression-free survival compared to paclitaxel alone.

Study data

The new trial results come from the first analysis of the phase III "Avastin and Docetaxel" ("AVADO", BO17708) study which investigated the addition of docetaxel chemotherapy to Avastin administered either at 7.5 or 15 mg/kg every three weeks. Both doses of Avastin in combination with the chemotherapy showed statistically significant improvements in the time patients live without their disease advancing as measured by progression-free survival, compared to chemotherapy alone.

13th February 2008

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