Genentech updates Avastin label with thromboembolic risk

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. (Source: Reuters Health: Oncolink: January 2005.)