FDA Grants BLA Status for Zaltrap

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(ChemotherapyAdvisor) – Expedited approval might be in the cards for Zaltrap (aflibercept), an investigational agent for treatment of metastatic colorectal cancer (mCRC). That news comes as Sanofi Oncology and Regeneron Pharmaceuticals, Inc. have been granted Priority Review of the Biologics License Application (BLA) by the FDA for Zaltrap (aflibercept) concentrate for infusion in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen. Zaltrap, also known in the scientific literature as VEGF Trap, is an investigational angiogenesis inhibitor with a unique mechanism of action: VEGF Trap competes with multiple forms of Vascular Endothelial Growth Factor and inhibits their binding to cognate receptors, thus inhibiting angiogenesis.

From the FDA, a Priority Review designation is given to drugs if preliminary estimates indicate that the drug product, if approved, has the potential to provide a treatment where no adequate therapy exists or offers a significant improvement compared to market products. Under Priority Review, the target date for an FDA decision on the Zaltrap BLA is August 4, 2012. The basis for the filing was the Phase 3 Velour study: 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 trial's main endpoints included an improvement in overall survival and safety.

"Sanofi and Regeneron are committed to the continued development of Zaltrap and we are very pleased that the FDA has chosen to grant Priority Review to Zaltrap in metastatic colorectal cancer," said Debasish Roychowdhury, MD, Senior Vice President and Head, Sanofi Oncology.  "We look forward to working closely with the FDA to potentially bring an important new option to patients with this difficult disease."

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