# Aflibercept

Aflibercept (Zaltrap, Sanofi Winthrop Industrie) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Colorectal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + irinotecan/5-fluorouracil/folinic acid (FOLFIRI) | 2nd line, metastatic | After oxaliplatin-containing regimen (resistant to or progressed after) |

## Products

### Zaltrap

- Company: Sanofi Winthrop Industrie
- Target: VEGF and PlGF trap fusion protein
- Class: Other antineoplastic agents
- ATC: L01XX44
- EU approval: 1 Feb 2013
- Label revised: 29 Aug 2024
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/zaltrap-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/zaltrap-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/zaltrap

Mechanism (SmPC section 5.1): Acts as a soluble decoy receptor binding VEGF-A, VEGF-B, and PlGF, preventing activation of cognate VEGF receptors to inhibit endothelial cell proliferation and tumour angiogenesis.

## Label wording

- **Aflibercept** (Zaltrap), Colorectal cancer, 2nd line, metastatic: “ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zaltrap-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/aflibercept
