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April 5, 2012 /PRNewswire/ -- 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.
"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, M.D., 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."
Separately, the companies today announced the results from the Phase III
VENICE trial evaluating the addition of the investigational agent ZALTRAP to a regimen of docetaxel and prednisone for the first-line treatment of metastatic androgen-independent prostate cancer. The study did not meet the pre-specified criterion of improvement in overall survival (OS). The safety profile was generally consistent with previous studies of ZALTRAP in combination with docetaxel.
The companies are conducting a detailed analysis of the
VENICE data, and full results will be presented at an upcoming medical meeting.
About the VELOUR Phase III Study
The VELOUR study was a multinational, randomized, double-blind trial comparing ZALTRAP versus placebo in combination with FOLFIRI in the treatment of patients with mCRC after failure of an oxaliplatin-based regimen. The study enrolled 1,226 patients with mCRC. The primary endpoint was an improvement in overall survival. Secondary endpoints included progression-free survival, response to treatment, and safety.