April 05, 2012

Sanofi and Regeneron Announce Regulatory and Clinical Update for Zaltrap® (aflibercept)

- Zaltrap BLA for Metastatic Colorectal Cancer Granted Priority Review by FDA -
- Zaltrap Phase III Study in Prostate Cancer Did Not Meet Primary Endpoint -

 

Sanofi and Regeneron Announce Regulatory and Clinical Update for Zaltrap® (aflibercept)
- Zaltrap BLA for Metastatic Colorectal Cancer Granted Priority Review by FDA -
- Zaltrap Phase III Study in Prostate Cancer Did Not Meet Primary Endpoint -

Paris, France and Tarrytown, NY – April 5, 2012 – Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (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-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen. 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 a significant improvement compared to marketed products. Under Priority Review, 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.