FDA Approves Zaltrap (Ziv-Aflibercept) for Metastatic Colorectal Cancer
Drug inhibits blood supply to tumors
On August 3, the FDA approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil, and irinotecan) chemotherapy regimen to treat adults with metastatic colorectal cancer.
Zaltrap is an angiogenesis inhibitor that reduces the blood supply to tumors. It is intended for patients with metastatic cancer whose tumors are resistant to or have progressed after an oxaliplatin-containing chemotherapy regimen.
Colorectal cancer is the fourth most commonly diagnosed cancer and the fourth leading cause of cancer death in the U.S. According to the National Institutes of Health, an estimated 143,460 Americans will be diagnosed with colorectal cancer and 51,690 will die from the disease in 2012.
The safety and effectiveness of Zaltrap were evaluated in a randomized clinical study of 1,226 patients with metastatic colorectal cancer whose disease progressed while receiving oxaliplatin-based combination chemotherapy, or whose cancer was removed by surgery but returned within 6 months after receiving oxaliplatin-based combination chemotherapy for post-surgery (adjuvant) treatment. Participants received treatment with Zaltrap plus FOLFIRI until their cancer progressed or side effects became unacceptable.
The study was designed to measure overall survival. Patients who were assigned to receive the Zaltrap-plus-FOLFIRI combination lived an average of 13.5 months compared with an average of 12.0 months for those receiving FOLFIRI plus placebo. A reduction in tumor size occurred in 20% of patients receiving Zaltrap plus FOLFIRI versus 11% of those receiving FOLFIRI plus placebo.
The most common side effects observed in patients treated withg Zaltrap plus FOLFIRI were a decreased white blood cell count, diarrhea, mouth ulcers, fatigue, high blood pressure, an increased amount of protein in the urine, weight loss, decreased appetite, abdominal pain, and headache.
Zaltrap is manufactured by sanofi-aventis.
For more information, visit the FDA's Web site.