Genentech updates Avastin label with thromboembolic risk
Last Updated: January 06, 2005



NEW YORK (Reuters) - Genentech Inc. said on Thursday it has updated
information on the package insert for its colon cancer drug Avastin
(bevacizumab) to reflect an increased risk of thromboembolism that
can lead to MIs and stroke.


The company, which first announced the potential risk last year, has
also sent a letter to physicians notifying them of the label change.
The final label reflects discussions with the U.S. Food and Drug
Administration, which analyzed information disclosed by Genentech.

Genentech, which is majority owned by Roche Holding AG, said last
August that the thromboembolic risk for patients taking Avastin plus
chemotherapy was as much as 5% compared with 1.9% in patients taking
chemotherapy alone. The risk in patients taking Avastin has now been
determined to be 4.4%, the company said.

The company said the risk of blood clots increased in patients over
the age of 65.

Avastin, which was approved in February last year, is the first U.S.-
approved anti-angiogenesis drug. It has been shown to extend the life
of colon cancer patients by an average of 5 months.

The warning last August has done little to affect sales of Avastin,
which costs $4,400 a month.





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