Sanofi and Regeneron announced that the FDA approved Zaltrap (ziv-aflibercept) injection for infusion, in combination with FOLFIRI (5-fluorouracil, leucovorin, irinotecan [Camptosar; Pfizer]) for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin (Eloxatin; Sanofi Aventis)-containing regimen.
Zaltrap was approved following a priority review by the FDA. The approval was based on data from the multinational, randomized, double-blind Phase 3 VELOUR trial (n=1,226) comparing FOLFIRI in combination with either Zaltrap or placebo in the treatment of patients with mCRC. Results showed that in patients previously treated with an oxaliplatin containing regimen, adding Zaltrap to FOLFIRI significantly improved median survival from 12.06 months to 13.50 months (HR=0.817, 95% CI 0.714– 0.935; p=0.0032), an 18% relative risk reduction.
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.
Sanofi plans to make Zaltrap injection available in the third quarter of 2012.