Zaltrap Approved for Advanced Colorectal Cancer
FRIDAY, Aug. 3 -- Zaltrap (ziv-afilbercept) has been approved by the U.S. Food and Drug Administration in combination with a FOLFIRI chemotherapy regimen for adults with advanced metastatic (spreading) colorectal cancer, the agency said Friday.
FOLFIRI stands for a regimen that includes folinic acid, fluorouracil and irinotecan. Zaltrap, among a class of drugs called angiogenesis inhibitors, restricts tumor growth by inhibiting their blood supply. The drug was approved for people whose tumors are resistant to or have progressed after oxaliplatin-based chemotherapy, the FDA said in a news release.
Colorectal cancer, the 4th-leading cause of cancer and cancer deaths in the United States, will be diagnosed in an estimated 143,460 Americans this year, and about 51,690 will die from it, the agency said.
In clinical testing, people who received the Zaltrap-FOLFIRI combination lived an average of 13.5 months, compared to 12 months with a combination of FOLFIRI and a placebo, the FDA said.
The most common side effects of the Zaltrap-FOLFIRI combination included decreased white blood cells, diarrhea, mouth ulcers, fatigue, high blood pressure, weight loss, loss of appetite, abdominal pain and headache.
Zaltrap is produced by Sanofi-Aventis, based in Bridgewater, N.J.
To learn more about colorectal cancer, visit the U.S. National Cancer Institute.
Posted: August 2012