Warning about Tracheoesophageal Fistula w/ Avastin (July 07)

Genentech recently alerted healthcare professionals about patients with limited-stage small cell lung cancer who developed tracheoesophageal (TE) fistulae after receiving a treatment regimen that included Avastin. Avastin (bevacizumab) is approved to treat certain patients with non-small cell lung cancer and colorectal cancer, but it is not approved for small cell lung cancer.

The patients were enrolled in a clinical study of combined chemotherapy and radiation plus Avastin. Two confirmed cases of TE fistula, one of them fatal, were reported in the first 29 patients enrolled in this study. Another fatal event was also reported, where TE fistula was suspected but not confirmed. All three events occurred during the Avastin maintenance phase of the study in patients who had been experiencing persistent esophagitis. Patient enrollment in the study has been stopped.

The current labeling describes GI fistulae in patients with colorectal and other types of cancer who were given Avastin. Genentech says the company will update the product label to provide more detailed information on the incidence of all cases of fistula in patients treated with Avastin.

Additional Information:

FDA MedWatch Safety Alert. Avastin (bevacizumab). April 21, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avastin

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News & Politics

Tags:

• Avastin
• Warning
• Bevacizumab
• FDA
• Fistula
• Lung
• Cancer
• TE
• Drug
• Reaction