The U.S. Food and Drug Administration (FDA) has approved Zaltrap® (ziv-aflibercept) for use in combination with the FOLFIRI chemotherapy regimen (folinic acid, fluorouracil, and ironotecan) to treat adults with metastatic colorectal cancer.
Colorectal cancer remains the second leading cause of cancer-related death in the United States. Metastatic colorectal cancer refers to cancer that has spread from the colon to distant sites in the body.
Targeted therapies are anticancer drugs that interfere with specific pathways involved in cancer cell growth or survival. Zaltrap is a type of targeted therapy called an angiogenesis inhibitor. It works by inhibiting the blood supply to tumors. Zaltrap is intended for use in metastatic cancer that is resistant to or that has progressed after a chemotherapy regimen containing oxaliplatin.
The approval was based on the results of a randomized clinical trial that included 1,266 patients with metastatic cancer. The patients had experienced cancer progression or return after treatment with oxaliplatin-based chemotherapy. Participants in the study were randomly assigned to receive treatment with Zaltrap plus FOLFIRI or FOLFIRI plus placebo until their cancer progressed or side effects became unacceptable. The study was designed to measure overall survival.
The results indicated that Zaltrap was associated with an improvement in response rate and median survival time and a delay in tumor progression and growth. Patients in the Zaltrap/FOLFIRI group lived an average of 13.5 months compared to an average of 12 months for patients in the placebo group. Twenty percent of patients in the Zaltrap group experienced a reduction in tumor size, compared with only 11 percent in the placebo group. Zaltrap was also associated with an improvement in progression-free survival—patients in the Zaltrap group lived for 6.9 months before their cancer progressed, compared with 4.7 months in the placebo group.
The most common side effects observed in patients receiving Zaltrap/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.
Zaltrap is being approved with a Boxed Warning as the drug can cause severe and sometimes fatal bleeding, including gastrointestinal bleeding and the development of holes in the gastrointestinal tract.
FDA approves Zaltrap for metastatic colorectal cancer. [FDA News Release]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm314372.htm