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8/13/2004

Avastin Linked With Thromboembolism

Kate Traynor

In a warning dated yesterday, the Food and Drug Administration (FDA) advised health care providers that patients who are administered bevacizumab, which is sold by Genentech Inc. as Avastin, are at increased risk for serious thromboembolic events.

According to FDA and the manufacturer (PDF), clinical trial data indicate that 5 percent of patients treated with bevacizumab and fluorouracil-based chemotherapy for metastatic colorectal cancer suffered a thromboembolic event. Such adverse events occurred twice as often among bevacizumab recipients as in patients receiving an active comparator therapy.

Specifically, patients who received bevacizumab were at increased risk for stroke, myocardial infarction, transient ischemia, and angina and were at increased risk of dying from the thromboembolic event.

Genentech announced that it is revising the labeling for becacizumab to reflect the new information. The company advised health care providers to report serious adverse events involving bevacizumab to Genentech or to FDA's MedWatch program.

FDA licensed bevacizumab in February for first-line treatment of metastatic colon or rectal cancer. Bevacizumab is an angiogenesis inhibitor, the only product in this class licensed for use in the United States.