The FDA and Genentech have notified health professionals of important new safety information regarding Avastin. This information concerns tracheoesophageal (TE) fistula formation that occurred in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC). These patients were receiving concurrent chemotherapy and radiation plus Avastin.

Two confirmed serious adverse events of TE fistula (one fatal) were 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. These events occurred during the maintenance phase of the study in the context of persistent esophagitis.

Avastin, in combination with intravenous 5-fluorouracil based chemotherapy, is indicated for first or second line treatment of patients with metastatic carcinoma of the colon or rectum, in addition to the first line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer in combination with carboplatin and paclitaxel. Avastin is not approved for the treatment of SCLC.