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U.S. Department of Health and Human Services

Safety

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Avastin (bevacizumab) Jan 2005

Audience: Oncologists and other healthcare professionals

FDA and Genentech notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS, ADVERSE EVENTS, and DOSAGE AND ADMINISTRATION sections of the Avastin labeling. Avastin, used in combination with intravenous 5-fluorouracil–based chemotherapy, is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum. Arterial thromboembolic events, including cerebral infarction, transient ischemic attacks (TIAs), myocardial infarction (MI), and angina, occurred at a higher incidence in patients receiving Avastin in combination with chemotherapy as compared to those receiving chemotherapy alone. These events were fatal in some instances.

In randomized, active-controlled studies, the overall incidence of arterial thromboembolic events was increased with the use of Avastin in combination with chemotherapy (4.4% vs. 1.9%). The incidences of both cerebrovascular arterial events (1.9% vs. 0.5%) and cardiovascular arterial events (2.1% vs. 1.0%) were increased in patients receiving Avastin in combination with chemotherapy. In addition, there was a correlation between age (65 years and over) and the increase in risk of thromboembolic events. The risk of these events should be viewed in the context of Avastin's ability to improve overall survival in patients with metastatic colorectal cancer.

[January 5, 2005 - Letter - Genentech]