The U.S. Food and Drug Administration today approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan)
chemotherapy regimen to treat adults with
colorectal cancer.
Zaltrap is an angiogenesis inhibitor that inhibits the blood supply to tumors. It is intended for patients whose cancer has spread to other parts of the body (metastatic) and whose tumors are resistant to or 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 United States. According to the National Institutes for Health, an estimated 143,460 Americans will be diagnosed with colorectal cancer and 51,690 will die from the disease in 2012.
"This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "An improvement in median survival time was noted with the addition of Zaltrap to FOLFIRI, accompanied by an improvement in response rate and a delay in tumor progression and growth."
Zaltrap's safety and effectiveness was evaluated in a randomized clinical study of 1,226 patients with metastatic colorectal cancer whose cancer grew while receiving oxaliplatin-based combination chemotherapy, or whose cancer was removed by surgery but returned within six months after receiving oxaliplatin-based combination chemotherapy for post-surgery (adjuvant) treatment. Participants received treatment until their cancer progressed or side effects became unacceptable.