Sanofi and Regeneron mCRC drug Zaltrap misses goals but gets FDA priority

The US Food and Drug Administration 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-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen.

The drug is under development by USA-based Regeneron Pharmaceuticals (Nasdaq: REGN) and partner French drug major Sanofi (Euronext: SAN). Last year, Decision Resources forecast that Zaltrap would achieve peak sales of $250 million in the second-line setting for colorectal cancer, but this could be a lot more if it gains approval as a first-line treatment (The Pharma Letter May 13, 2011).

The target date for an FDA decision on the Zaltrap BLA is August 4, 2012. The filing was based on the Phase III VELOUR study in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen. Priority review is given to drugs if preliminary estimates indicate that the product, if approved, has the potential to provide a treatment where no adequate therapy exists or it shows significant improvement compared with marketed products.