FDA MedWatch: Avastin (bevacizumab) and Formation of Tracheoesophageal Fistula in a Recent Clinical Study in Patients with Limited-stage Small Cell Lung Cancer
ROCKVILLE, Md., April 21, 2007-Genentech and FDA notified
healthcare professionals of important new safety information
regarding tracheoesophageal (TE) fistula formation in a recent
clinical study in patients with limited-stage small cell lung
cancer (SCLC). This multicenter, non-randomized, single-arm phase
II clinical trial study combined chemotherapy and radiation plus
Avastin. There have been two confirmed serious adverse events of TE
fistula (one fatal) reported in the first 29 patients enrolled in
this study.
A third, fatal event (upper aerodigestive tract hemorrhage and
death of unknown cause), was also reported, in which TE fistula was
suspected but not confirmed. All three events occurred during the
Avastin maintenance phase of the study in the context of persistent
esophagitis. Additionally, six other cases of TE fistula have also
been reported in other lung and esophageal cancer studies using
Avastin and chemotherapy alone or with concurrent radiation
treatment.
Avastin is not approved for the treatment of SCLC. The current prescribing information includes a description of gastrointestinal tract fistula formation in patients with colorectal cancer and other types of cancer treated with Avastin. Genentech intends to revise the Avastin package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with Avastin. Read the complete MedWatch 2007 Safety Alert with links to the Genentech Dear Healthcare Professional Letter and the most recent Avastin labeling, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avastin
Posted: April 2007
