FDA priority review for Zaltrap (Regeneron/Sanofi) for Colorectal Cancer

The FDA has granted priority review of the Biologics License Application for Zaltrap (aflibercept) from Regeneron/Sanofi in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen. A target date for a decision by the agency has been set for August 4. The filing was based on the Phase III VELOUR study which compared Zaltrap in combination with the FOLFIRI chemotherapy regimen versus FOLFIRI plus placebo. The trial met its primary endpoint of improving overall survival in the second-line treatment of mCRC