Drug updated on 4/17/2024

Dosage FormInjection (intravenous; 100 mg/4 mL [25 mg/mL], 200 mg/8 mL [25 mg/mL])
Drug ClassVascular endothelial growth factor inhibitors
Ongoing and
Completed Studies


  • Indicated for use in combination with FOLFIRI (fluorouracil, leucovorin, irinotecan) for the treatment of metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin regimen.

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  • Ziv-aflibercept (Zaltrap) is a recombinant fusion protein that serves as a decoy receptor for vascular endothelial growth factors. It is used in combination with FOLFIRI for second-line salvage chemotherapy in metastatic colorectal cancer following resistance or progression after an oxaliplatin regimen.
  • Seven systematic reviews/meta-analyses were analyzed to gather information about the safety and effectiveness of Zaltrap compared to other therapies.
  • When combined with FOLFIRI, Zaltrap exhibits significant antiangiogenic adverse events such as grade III/IV hypertension, proteinuria, and hemorrhagic events more frequently than control treatments. Additionally, it shows an increased risk of hypertension and proteinuria compared to other biological agents like bevacizumab, ramucirumab, and regorafenib.
  • Despite these safety concerns, studies indicate that Zaltrap offers improved efficacy over chemotherapy alone or FOLFIRI alone in terms of progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). This makes it a competitive option against medications such as regorafenib and bevacizumab, particularly in the second-line treatment setting for metastatic colorectal cancer (mCRC).
  • The safety profile does not notably differ based on the treatment line or chemotherapy regime, indicating consistency across different subgroups. However, high-grade adverse events associated with this drug include neutropenia and venous thromboembolic events, along with common side effects like diarrhea, weakness, stomatitis, etc.
  • Economic analyses have raised concerns regarding the cost-effectiveness of ziv-aflibercept (Zaltrap) compared to FOLFIRI alone or other biological options within the mCRC treatment landscape. This is due to a lack of cost advantage despite its favorable effect on tumor response and survival metrics, which complicates the overall clinical value proposition.

Product Monograph / Prescribing Information

Document TitleYearSource
Zaltrap (ziv-aflibercept) Prescribing Information.2020Sanofi-Aventis U.S. LLC, Bridgewater, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines