Sanofi and Regeneron Pharmaceuticals, Inc, recently announced that the FDA has granted Priority Review of the Biologics License Application (BLA) for the investigational agent aflibercept (Zaltrap) concentrate for solution for infusion in combination with irinotecan/fluoropyrimidine–based chemotherapy in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen. Under Priority Review, the target date for an FDA decision on the aflibercept BLA is August 4, 2012. The filing was based on the phase III VELOUR study in 1,226 patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.
Aflibercept, also known in the scientific literature as VEGF Trap, is an investigational angiogenesis inhibitor with a unique mechanism of action. This fusion protein binds multiple forms of vascular endothelial growth factor-A (VEGF-A), as well as VEGF-B and placental growth factor. ■