The FDA approved the angiogenesis inhibitor ziv-aflibercept (Zaltrap; sanofi- aventis/Regeneron) for use in combination with a FOLFIRI (folinic acid, fluorouracil, and irinotecan) chemotherapy regimen for the treatment of adults with metastatic colorectal cancer (CRC) whose tumors are resistant to or progressed after an oxaliplatin-containing chemotherapy regimen.
The approval was based on a randomized clinical trial of 1226 patients with metastatic CRC whose cancer grew while receiving oxaliplatin-based combination chemotherapy, or whose cancer was removed but returned within 6 months. Patients who received the ziv-aflibercept plus FOLFIRI combination lived an average of 13.5 months compared with 12 months in those receiving FOLFIRI plus placebo; tumor size reduction was 20% versus 11%, respectively. Progression-free survival was 6.9 months versus 4.7 months, respectively.
Zaltrap was approved with a boxed warning regarding the potential for severe internal bleeding and the development of holes in the gastrointestinal tract. The most common side effects were decreased white blood cell count, diarrhea, mouth ulcers, fatigue, hypertension, increased amount of protein in the urine, weight loss, decreased appetite, abdominal pain, and headache. (August 3, 2012)
