FDA Approved Drugs » 2012
Medical Areas: Gastroenterology | Oncology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved August 2012
Treatment Area: metastatic colorectal cancer
Zaltrap (ziv-aflibercept) is a fusion protein specifically designed to bind all forms of Vascular Endothelial Growth Factor-A (VEGF-A) and Placental Growth Factor (PlGF). Both VEGF-A and PlGF are proteins that are involved in the abnormal growth of new blood vessels.
Zaltrap is specifically approved in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI) for patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen.
Zaltrap is supplied as an injection for intravenous infusion. The recommended dose is 4 mg per kg over one hour every two weeks. Administer Zaltrap prior to any component of the FOLFIRI regimen on the day of treatment. Zaltrap should be continued until disease progression or unacceptable toxicity.
FDA ApprovalThe FDA approval of Zaltrap for colorectal cancer was based on a randomized, double-blind, placebo-controlled study in 1,226 subjects with metastatic colorectal cancer who were resistant to or had progressed during or within six months of receiving oxaliplatin-based combination chemotherapy, with or without prior bevacizumab. The subjects received either Zaltrap (4 mg per kg) as a one hour intravenous infusion on day 1) or placebo, each in combination with 5-fluorouracil plus irinotecan (FOLFIRI). The treatment cycles on both arms were repeated every two weeks.Treatment continued until disease progression or unacceptable toxicity. The primary efficacy endpoint was overall survival. The median overall survival was 13.50 months in the Zaltrap/FOLFIRI arm versus 12.06 months in the placebo/FOLFIRI arm. Median progression free survival was 6.90 months in the Zaltrap/FOLFIRI arm versus 4.67 months in the placebo/FOLFIRI arm. The Overall Response Rate (Complete response + Partial Response) was 19.8% in the Zaltrap/FOLFIRI arm versus 11.1% in the placebo/FOLFIRI arm (p=0.0001).
Adverse events associated with the use of Zaltrap for colorectal cancer may include, but are not limited to, the following:
Ziv-aflibercept is a recombinant fusion protein consisting 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. By binding to these endogenous ligands, ziv-aflibercept can inhibit the binding and activation of their cognate receptors. This inhibition can result in decreased neovascularization and decreased vascular permeability. Ziv-aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system.
For additional information regarding Zaltrap or colorectal cancer, please visit the Zaltrap web page.
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