The FDA today approved Zaltrap (zif-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen for the treatment of adults with colorectal cancer.
Zaltrap is an angiogenesis inhibitor that inhibits 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.
The safety and effectiveness of Zaltrap 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.
The study was designed to measure overall survival, or the length of time a patient lived. Patients who were assigned to receive the Zaltrap plus FOLFIRI combination lived an average of 13.5 months compared to an average of 12 months for those receiving FOLFIRI plus placebo. A reduction in tumor size occurred in 20% of patients receiving the Zaltrap plus FOLFIRI combination versus 11% for those receiving FOLFIRI plus placebo.
Additionally, the clinical trial demonstrated an improvement in progression-free survival, or the time a patient lived without the cancer progressing. The progression-free survival for patients receiving the Zaltrap plus FOLFIRI combination was 6.9 months compared with 4.7 months for those receiving FOLFIRI plus placebo.
Zaltrap’s approval comes 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 perforations in the gastrointestinal tract. Zaltrap can also prolong healing time for wounds.
The most common side effects observed in patients receiving Zaltrap plus FOLFIRI were decreased white blood cell count (leucopenia), diarrhea, mouth ulcers, fatigue, high blood pressure, increased amount of protein in the urine, weight loss, decreased appetite, abdominal pain, and headache.
Zaltrap is manufactured by Bridgewater, N.J.-based sanofi-aventis.