Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) on Thursday said that the Biologics License Application for the investigational agent Zaltrap (aflibercept) concentrate for solution has been granted priority review by the Food and Drug Administration.
Zaltrap is proposed for infusion in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer, or 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 products already available on the market.
Under priority review, the target date for an FDA decision on the Zaltrap BLA is August 4. The filing was based on the Phase III Velour study in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.
Separately, the companies announced the results from the Phase III VENICE trial evaluating the addition of 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. 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.
For comments and feedback contact: editorial@rttnews.com
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.