The FDA announced it has given its approval for Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer. It is intended for use in patients whose cancer has been resistant to or progressed after oxaliplatin-containing chemotherapy regimen. Zaltrap was co-developed by Sanofi and Regeneron Pharmaceuticals Inc.
Colorectal cancer is the 4th most common type of cancer in the U.S. in men and women. It is also the 4th leading cause of cancer deaths in the U.S. Over 140,000 Americans will be diagnosed with colorectal cancer this year. Nearly 50,000 of them will die from the disease. “There are limited treatment options for metastatic colorectal cancer patients who are resistant to or whose disease has progressed after an oxaliplatin-containing regimen,” said Edith Mitchell, M.D., Clinical Professor of Medicine and Medical Oncology at Jefferson Medical College of Thomas Jefferson University and an investigator of the VELOUR pivotal study. ”The approval of ZALTRAP in combination with a FOLFIRI chemotherapy regimen offers another treatment option and is welcome news for metastatic colorectal patients and their physicians.”
Zaltrap is an angiogenesis inhibitor which means that it prevents the growth of new blood vessels forming in tumors. The basic idea is to starve the tumors blood supply to prevent them from growing. According to the Sanofi press release, “adding ZALTRAP to FOLFIRI significantly improved median survival from 12.06 months to 13.50 months, an 18 percent relative risk reduction”. Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said, “This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI,… 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.”
Below, you can see an embedded video that describes Zaltrap and its benefits in more detail.
One thing to note with this approval is the box warning that warns patients and doctors that it can cause severe and sometimes fatal bleeding, including gastrointestinal bleeding, and the development of holes in the gastrointestinal tract.