# Fruquintinib

Fruquintinib (Fruzaqla, Takeda Pharmaceuticals International AG Ireland) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Colorectal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+, metastatic | After available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and progressed on or intolerant to either trifluridine-tipiracil or regorafenib |

## Products

### Fruzaqla

- Company: Takeda Pharmaceuticals International AG Ireland
- Target: VEGFR tyrosine kinase inhibitor
- Class: Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
- ATC: L01EK
- EU approval: 20 Jun 2024
- Label revised: 21 Sep 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/fruzaqla-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/fruzaqla-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla

Mechanism (SmPC section 5.1): Fruquintinib selectively inhibits VEGFR-1, -2, and -3 tyrosine kinases, producing antitumor effects by suppressing tumour angiogenesis.

## Label wording

- **Fruquintinib** (Fruzaqla), Colorectal cancer, 3rd line+, metastatic: “FRUZAQLA as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/fruzaqla-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/fruquintinib