Fruquintinib
Vascular Endothelial Growth Factor Receptor (Vegfr) Tyrosine Kinase Inhibitors
Sold as FRUZAQLA
- Drug class
- Vascular Endothelial Growth Factor Receptor (Vegfr) Tyrosine Kinase Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 7
- FDA reports (12 mo)
- 1,457
Overview
Plain-language summary, compiled from the cited regulatory records
Fruquintinib is a type of drug known as a Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor [1]. It is approved for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have previously received certain therapies [1]. These prior treatments include fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, as well as anti-VEGF therapy [1]. If the patient's RAS is wild-type and it is medically appropriate, prior anti-EGFR therapy is also a requirement [1].
Fruquintinib is available under the brand name Fruzaqla [1]. In the past 12 months, there have been 1457 adverse event reports associated with this active ingredient [2]. The most frequently reported adverse events include death, metastatic colorectal cancer, fatigue, colon cancer, and hypertension [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 3 | August 15, 2025 |
| CA Canada | Health Canada | 2 | March 22, 2025 |
| US United States | FDA | 1 | February 5, 2026 |
| EU European Union | EMA | 1 | November 27, 2024 |
GBUnited Kingdom· MHRA
3 products
Uses
FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with or without an anti-VEGF therapy, and if RAS wildtype and medically appropriate, an anti-EGFR therapy.
How to take
CACanada· Health Canada
2 products
Uses
FRUZAQLA (fruquintinib capsules) is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are not considered candidates for available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, an anti-EGFR agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.
1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥ 65 years of age): There were no observed overall differences in safety and effectiveness of FRUZAQLA in geriatric compared to younger patients.
How to take
USUnited States· FDA
1 product
Uses
1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
( 1 )
How to take
EUEuropean Union· EMA
1 product
Uses
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.
3
How to take
Sources & citations
- [1]MHRA (UK) · PL161890147 · revised August 15, 2025
- [2]Health Canada (DPD) · 02551454 · revised March 22, 2025
- [3]FDA DailyMed · 186d786e-dc8a-45… · revised February 5, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/005979 · revised November 27, 2024
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.