ZURICH (AFX) - Roche Holding AG unit Genentech Inc said the US Food and Drug Administration (FDA) has approved an updated product label for Avastin, which is approved as a combination treatment for patients with first-line or previously untreated-metastatic colorectal cancer.
The updated product label is a reply to a 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, Genentech said.
An analysis of 1,745 patients treated in Avastin clinical trials showed that ATEs occurred in 4.4 pct of patients treated with Avastin, compared with 1.9 pct of patients who received chemotherapy alone.
ATEs are defined in the label as stroke transient ischemic attacks, heart attack, angina and other arterial thromboembolic events.
at/wf
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The updated product label is a reply to a 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, Genentech said.
An analysis of 1,745 patients treated in Avastin clinical trials showed that ATEs occurred in 4.4 pct of patients treated with Avastin, compared with 1.9 pct of patients who received chemotherapy alone.
ATEs are defined in the label as stroke transient ischemic attacks, heart attack, angina and other arterial thromboembolic events.
at/wf
For more information and to contact AFX: www.afxnews.com and www.afxpress.com
© 2005 AFX News
