FRUZAQLA® (fruquintinib) safety profile in FRESCO

The majority of adverse reactions (ARs) in FRESCO with FRUZAQLA were predictable and manageable1-3

FRESCO was a single-country study that evaluated fruquintinib safety and efficacy1,2

ARs that occurred in ≥10% of patients1

In the FRESCO clinical trial, adverse reactions occurring in ≥10% of patients included hypertension, proteinuria, palmar-plantar erythrodysesthesia, dysphonia, stomatitis, abdominal pain, hemorrhage, diarrhea, fatigue, musculoskeletal pain, anorexia, hypothyroidism, back pain, arthralgia, and throat pain.
aRepresents a composite of multiple related terms.
  • Predictable is defined as ARs that are consistent with inhibition of VEGF and VEGFR*3
  • Serious ARs occurred in 15% of patients treated with FRUZAQLA + BSC. Serious ARs in ≥2% of patients treated with FRUZAQLA + BSC included intestinal obstruction (2.9%) and hemorrhage (2.2%)1
  • Fatal ARs occurred in 7 (2.5%) patients treated with FRUZAQLA + BSC, including cerebral infarction (n=1), gastrointestinal hemorrhage (n=1), hemoptysis (n=1), bacterial infection (n=1), lung/lower respiratory infection (n=2), and multiple organ dysfunction (n=1)1

*Despite predictability, individual patient experiences may vary.

Low Grade 3/4 laboratory abnormalities were observed with FRUZAQLA 1

Select laboratory abnormalities worsening from baseline and occurring in ≥20% of patients1,a,b

In the FRESCO clinical trial, select laboratory occurring in ≥20% of patients included an increase in creatinine, glucose, aspartate aminotransferase, alkaline phosphatase, bilirubin, and alanine aminotransferase and a decrease in sodium, platelets, urate, calcium, hemoglobin, and potassium.

aGraded according to NCI CTCAE version 4.03.1
bEach test incidence is based on the number of patients who had both baseline and at least one on‑study laboratory measurement available: FRUZAQLA (range: 257-277) and placebo (range: 126-134).1

Manageable safety profile with FRUZAQLA as demonstrated in the FRESCO trial1

Dose interruptions or reductions due to ARs1
  • Dose interruptions: 35.3% with FRUZAQLA + BSC vs 10.2% with placebo + BSC
  • Dose reductions: 24.1% with FRUZAQLA + BSC vs 4.4% with placebo + BSC
Low rate of discontinuations.
Low rate of discontinuations due to ARs1,2
  • 15% with FRUZAQLA + BSC vs 6% for placebo + BSC

FRESCO Efficacy Results

Learn about the efficacy results from FRESCO, a single-country study of patients with previously treated mCRC.

FRESCO-2 Safety Profile

Explore the safety profile of FRUZAQLA from the FRESCO-2 clinical trial.

AR=adverse reaction; BSC=best supportive care; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; VEGF=Vascular endothelial growth factor; VEGFR=Vascular endothelial growth factor receptor.