The FDA recently approved Zaltrap (ziv-aflibercept) for combination use with a FOLFIRI (folinic acid, fluorouracil, and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.
Colorectal cancer is the fourth most commonly diagnosed cancer and also the fourth leading cause of cancer death in the United States. An estimated 143,460 Americans will be diagnosed with colorectal cancer, and 51,690 will die of the disease in 2012, according to the National Institutes of Health.
Ziv-aflibercept is an angiogenesis inhibitor that inhibits the blood supply to tumors. It is intended for patients whose cancer has metastasized and whose tumors are resistant to or have progressed after an oxaliplatin-containing chemotherapy regimen.
“This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
The safety and effectiveness of ziv-aflibercept was evaluated in a randomized clinical study of 1226 patients with metastatic colorectal cancer. Participants’ cancer either developed while receiving oxaliplatin-based combination chemotherapy, or it was removed by surgery but returned within 6 months after receiving oxaliplatin-based combination chemotherapy for postsurgery treatment. Participants received ziv-aflibercept treatment until their cancer progressed or side effects became unacceptable.
Designed to measure overall survival, the study showed that patients who received the ziv-aflibercept plus FOLFIRI combination lived an average of 13.5 months compared with an average of 12 months for those treated with FOLFIRI plus placebo. Twenty percent of patients receiving the ziv-aflibercept plus FOLFIRI combination achieved a reduction in tumor size, compared with 11% of those treated with FOLFIRI plus placebo.
In addition, the clinical trial demonstrated an improvement in progression-free survival. For patients receiving the ziv-aflibercept plus FOLFIRI combination, progression-free survival was 6.9 months, compared with 4.7 months for those receiving FOLFIRI plus placebo.
Ziv-aflibercept is being approved with a boxed warning alerting patients and healthcare professionals that the drug can cause severe and sometimes fatal bleeding, including gastrointestinal bleeding, and the development of holes in the gastrointestinal tract. Ziv-aflibercept can also make it more difficult for wounds to heal.
The most common side effects observed in patients receiving ziv-aflibercept plus FOLFIRI were decreased white blood cell count, diarrhea, mouth ulcers, fatigue, high blood pressure, increased amount of protein in the urine, weight loss, decreased appetite, abdominal pain, and headache.
Source: FDA.