Sanofi and Regeneron announced that the FDA has granted Priority Review of the Biologics License Application (BLA) for the investigational agent Zaltrap (aflibercept) concentrate for solution for infusion in combination with the irinotecan (Camptosar; Pfizer Inc)-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin (Eloxatin; Sanofi Aventis)-containing regimen.
The filing was based on the Phase 3 VELOUR study in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen. The study was a multinational, randomized, double-blind trial comparing Zaltrap vs. placebo in combination with FOLFIRI in the treatment of patients with mCRC after failure of an oxaliplatin-based regimen. The study enrolled 1,226 patients with mCRC. The primary endpoint was an improvement in overall survival. Secondary endpoints included progression-free survival, response to treatment, and safety.
Zaltrap is an angiogenesis inhibitor. This fusion protein binds all forms of vascular endothelial growth factor-A (VEGF-A), as well as VEGF-B and placental growth factor (PIGF), additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation. Zaltrap has been shown to bind VEGF-A, VEGF-B, and PlGF with higher affinity than their native receptors.