Published November 20, 2014
Sanofi and its US-based partner Regeneron Pharmaceuticals said Thursday their experimental drug Zaltrap missed targeted goals in a late-stage clinical trial for treating prostate cancer but that US regulators are giving it a fast-track review for use in treating colon cancer.
Sanofi said the Phase III VENICE trial involving 1,226 prostate cancer patients "did not meet the pre-specified criterion of improvement in overall survival."
The French drug maker added that the US Food and Drug Administration (FDA) had granted a priority review to the companies to examine Zaltrap in the treatment of colon cancer. That filing is based on a late-stage study, called VELOUR, in patients with colorectal cancer, whose disease has spread to other parts of the body and who have been previously treated with an oxaliplatin-containing regimen.
A fast-track 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.
The FDA is due to give a decision on its Zaltra priority review by Aug. 4.