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Roche halts Avastin trial recruitment
Roche has temporarily suspended recruitment in its trails using Avastin, following the deaths of four patients.
The Avant trial involved the use of Avastin and other drugs to prevent colon cancer reoccurring after surgery.
William Burns, chief executive of Roche Pharmaceuticals Division, told Bloomberg: “The difference in the number of deaths was not statistical or significant.
“We don’t even think the issue is linked to Avastin. We suspect it’s just an arithmetic anomaly but we’re taking a prudent approach.’
Avant principal investigator professor Aimery de Gramont, said: “The Avant trial provides a unique opportunity to assess the effect of combining an anti-angiogenic agent with standard chemotherapy in the adjuvant colon cancer setting.
“The temporary halting of the recruitment is necessary because in the adjuvant setting, the threshold for concern is particularly low.
“However, we look forward to exciting findings that will hopefully confirm the efficacy benefits that we have already observed in the metastatic setting. This will open the avenue for new options for patients suffering from colon cancer.”
In Europe, Avastin was approved last year for first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with chemotherapy.
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