A cancer treatment currently in clinical trials that”™s being developed by Regeneron Pharmaceuticals Inc. and Sanofi has been granted priority review by the U.S. Food and Drug Administration, the two companies announced April 5.
The treatment, known as Zaltrap, has been tested on patients with a specific type of colon cancer known as metastatic colorectal cancer.
“This is our lead cancer therapeutic and therefore this positive development at FDA is something that”™s clearly good for Regeneron and good for cancer patients if the drug can come to market,” said Regeneron spokesman Peter Dworkin. “It”™s one of the many drugs we have in our pipeline.”
Regeneron, based in Tarrytown, has been developing the drug for approximately ten years.
“Approval ”“ if we get it ”“ would be specifically for a subset of colon cancer patients who fit the type of patients and the stage of disease that we treated. The use of the drug would be limited to that at this time,” Dworkin said.
A priority review designation is handed down if preliminary estimates and clinical trials suggest that the drug, if approved, has the potential to provide a treatment where no adequate therapy exists or to significantly improve on currently-marketed products.
Under priority review, the target date for an FDA decision on the Zaltrap Biologics License Application (BLA) is August 4, 2012.
Zaltrap works by blocking a protein known as a vascular endothelial growth factor (VEGF), which is responsible for promoting the growth of blood vessels around tumors and thus allowing them to grow and spread.
