HealthDay News — The FDA has approved ziv-aflibercept (Zaltrap, Sanofi-Aventis) in combination with a FOLFIRI regimen for adults with advanced metastatic colorectal cancer.
FOLFIRI stands for a regimen that includes folinic acid, fluorouracil and irinotecan. Ziv-aflibercept is among a class of drugs called angiogenesis inhibitors, which 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 press release.
Colorectal cancer, the fourth-leading cause of cancer and cancer deaths in the United States, will be diagnosed in an estimated 143,460 Americans this year. About 51,690 of those diagnosed will die from the disease, the agency said.
Results from clinical trials show that patients assigned to the ziv-aflibercept-FOLFIRI combination lived an average of 13.5 months compared with 12 months among those assigned to a combination of FOLFIRI and a placebo.
The most common side effects of the ziv-aflibercept-FOLFIRI combination included decreased white blood cells, diarrhea, mouth ulcers, fatigue, high BP, weight loss, loss of appetite, abdominal pain and headache.