The ODAC reviewed data from all three studies (E2100, AVADO and RIBBON 1), which showed that Avastin plus commonly used chemotherapies (taxane-based, anthracycline-based or capecitabine chemotherapy) increased the time women lived without the disease growing or spreading (PFS), compared to the chemotherapies alone. In these studies, adverse events were generally consistent with those previously reported for Avastin and no new safety signals were observed.

Across the studies, the most common adverse events associated with Avastin treatment were high blood pressure (10.4 percent vs. 1.2 percent) and proteinuria (2.6 percent vs. 0 percent). The incidence of severe adverse events known to be associated with Avastin treatment included arterial thromboembolic events (1.9 percent vs. 0.3 percent), bleeding (1.6 percent vs. 0.4 percent), febrile neutropenia (5.0 percent vs. 3.5 percent), fistula (0.4 percent vs. 0.3 percent), gastrointestinal (GI) perforation (0.5 percent vs. 0.3 percent), left ventricular systolic dysfunction (LVSD) (1.5 percent vs. 0.2 percent), neutropenia (8.0 percent vs. 7.1 percent), sensory neuropathy (9.7 percent vs. 8.5 percent) and venous thromboembolic events (3.0 percent vs. 3.8 percent). In clinical trials across cancer types, serious and sometimes fatal side effects in people given Avastin included gastrointestinal perforation, surgery and wound healing complications, and severe bleeding.

SOURCE Genentech