Genentech, Inc.

Company finalizes Avastin label with previously announced safety information

Published in Cardiovascular Business Week, February 1st, 2005

Genentech, Inc., (DNA) announced that the U.S. Food and Drug Administration has approved an updated product label for Avastin (bevacizumab), which is approved in combination with intravenous 5-Fluorouracil-based chemotherapy as a treatment for patients with first-line - or previously untreated - metastatic colorectal cancer.

The updated product label is in follow-up to the letter issued to healthcare providers in August 2004, regarding an increased risk of arterial thromboembolic events (ATEs) associated with the use of Avastin in combination with chemotherapy.

An analysis of 1745 patients treated in Avastin clinical trials showed that ATEs occurred...

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Source: Cardiovascular Business Week (2005-02-01)

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