Regeneron-Sanofi cancer drug gets faster review
NEW YORK (AP) — Regeneron Pharmaceuticals Inc. and Sanofi said Thursday that the Food and Drug Administration will conduct a faster review of their drug Zaltrap as a treatment for colorectal cancer.
The companies said the FDA will conduct a six-month priority review of Zaltrap, and the agency is scheduled to make a decision by Aug. 4. The FDA conducts priority reviews of drugs that may offer significant advances in treatment or provide a treatment where no adequate therapy exists. Regeneron and Sanofi want to market Zaltrap in combination with chemotherapy for patients who have already been treated with a different chemotherapy regimen.
The companies also said Zaltrap did not meet its goals in a late-stage trial that evaluated the drug as a treatment for prostate cancer. They said patients who were treated with Zaltrap, the chemotherapy drug Taxotere and the steroid prednisone did not survive longer than patients treated with Taxotere, prednisone and a placebo.
Sanofi is based in France, and Regeneron is based in Tarrytown, N.Y.
Regeneron shares picked up $1.22 to $123.27 in afternoon trading, and Sanofi shares fell 76 cents, or 2 percent, to $36.92.
