NEW YORK (AP) -- The Food and Drug Administration on Friday approved a new colorectal cancer drug developed by French drugmaker Sanofi and Regeneron Pharmaceuticals Inc.
The FDA approved Zaltrap for use in combination with a common chemotherapy regimen called FOLFIRI. The drugs are intended to treat colorectal cancer that has metastasized and which has not responded to other chemotherapy treatments or progressed following treatment.
Zaltrap is designed to limit blood supply to tumors. It was discovered by Tarrytown, N.Y.-based Regeneron and licensed to Sanofi, and the companies will market the drug together in the U.S.
The FDA said colorectal cancer is the fourth-most common type of cancer, and about 143,000 cases are expected to be diagnosed in 2012. The agency said patients who were treated with Zaltrap and chemotherapy in clinical trials had median survival of 13.5 months from the start of treatment, compared to 12 months for patients who were treated with chemotherapy and a placebo.
Patients treated with Zaltrap also lived for 6.9 months before death or disease progression compared to 4.7 months for patients treated with the placebo and chemotherapy.
Shares of Sanofi rose $1.47, or 3.7 percent, to $41.49 in afternoon trading. Regeneron stock picked up 86 cents to $137.33.
- Food and Drug Administration
- chemotherapy regimen