On August 3, 2012, the United States Food and Drug Administration (USFDA) approved ziv-aflibercept injection ( Zaltrap, made by Sanofi and Regeneron Pharmaceuticals, Inc.) for use in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following treatment with an oxaliplatin‑containing regimen. Ziv-aflibercept (previously known as aflibercept) is a recombinant fusion protein that consists of vascular endothelial growth factor (VEGF)-binding portions from the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of the human IgG1 immunoglobulin.
The FDA has approved Aflibercept for patients with previously treated metastatic colorectal cancer.
Aflibercept (discussed in our previous blog post titled “Aflibercept Is Proving to be a Diverse and Effectual Product“) is referred to by Sanofi and Regeneron as ZALTRAP™ or VEGF Trap. This novel angiogenesis-targeting agent has demonstrated efficacy in treating metastatic colorectal cancer.
The approval, based primarily on results of the recent randomized Phase III trial called “VELOUR”, specifies the use of aflibercept in combination with FOLFIRI chemotherapy (5-FU, irinotecan, and leucovorin) in patients whose disease has progressed on or exhibited resistance to oxaliplatin (Eloxatin)-based chemotherapy.
Colorectal cancer is the 3rd most common cancer in the United States. In recent decades, an improved understanding of the role of the angiogenesis pathway in colorectal cancer has led to advancements in treatment.
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