FDA Approves Avastin for Second-Line Treatment of Metastatic Colon Ca

ROCKVILLE, Maryland—Avastin (bevacizumab, Genentech), in combination with FOLFOX4-oxaliplatin (Eloxatin)/5-FU/leucovorin—has received FDA approval for the second-line treatment of metastatic colorectal cancer.

The Avastin/FOLFOX4 combination was initially approved for the first-line treatment of metastatic colorectal cancer in February 2004. Avastin is a recombinant, humanized, monoclonal IgG1 antibody that binds to human vascular endothelial growth factor (VEGF) and inhibits its biological activity, resulting in antiangiogenesis

E3200 Results

The drug's new indication is based on a randomized, controlled, multicenter phase III trial (E3200) that enrolled 829 patients with advanced or metastatic colorectal cancer who had previously received irinotecan (Camptosar) and 5-FU as their initial treatment for metastatic disease or as an adjuvant therapy.

The open-label, three-arm, active-controlled trial randomized patients to receive Avastin alone, Avastin plus FOLFOX4, or FOLFOX4 alone. Accrual to the Avastin-alone arm was closed after a planned interim analysis found patients in that arm had a decreased survival, compared to those receiving FOLFOX4 alone.

In the two arms with full accrual, the Avastin/FOLFOX4 group had a significant 25% reduction in the risk of death, compared with the FOLFOX4-alone arm. This translated into a 33% improvement in overall survival. The median survival for patients receiving the combination therapy was 13.0 months vs 10.8 months for the FOLFOX4-alone arm.