Genentech and FDA Issue Warning on Bevacizumab
On April 21, the FDA and Genentech notified health care professionals of new safety information about the formation of tracheoesophageal (TE) fistulas in a clinical study of patients with small-cell lung cancer (SCLC). The trial combined chemotherapy and radiation plus bevacizumab (Avastin). One fatal and one serious adverse event of TE fistula have been confirmed among the first 29 patients enrolled in the study. A third, fatal event of suspected TE fistula was also reported but has not been confirmed. Six other cases of TE fistula have also been reported in other lung and esophageal cancer studies using bevacizumab.
Bevacizumab is not approved for the treatment of SCLC. Genentech intends to revise the bevacizumab package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with bevacizumab.
Complete information is available at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avastin