FRUZAQLA® (fruquintinib) safety profile in FRESCO-2

In FRESCO-2, the majority of adverse reactions (ARs) with FRUZAQLA were manageable and predictable1-3 

FRESCO-2 was a global, double-blind, placebo-controlled study that evaluated fruquintinib safety and efficacy1,2

ARs occurring in ≥10% of patients1

In the FRESCO-2 clinical trial, adverse reactions occurring in ≥10% of patients included fatigue, hypertension, stomatitis, abdominal pain, diarrhea, hypothyroidism, palmar­-plantar erythrodysesthesia, proteinuria, dysphonia, musculoskeletal pain, and arthralgia.

aRepresents a composite of multiple related terms.1

  • Predictable refers to ARs consistent with inhibition of VEGF and VEGFR*1
  • Serious ARs occurred in 38% of patients treated with FRUZAQLA + BSC. Serious ARs in ≥2% of patients treated with FRUZAQLA + BSC included hemorrhage (2.2%) and gastrointestinal perforation (2.0%)1
  • Fatal ARs occurred in 14 (3.1%) patients treated with FRUZAQLA + BSC. Fatal ARs occurring in ≥2 patients treated with FRUZAQLA + BSC include pneumonia (n=3), sepsis/septic shock (n=2), and hepatic failure/encephalopathy (n=2)1

*Despite predictability, individual patient experiences may vary

FRUZAQLA had low grade 3/4 laboratory abnormalities1

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

In the FRESCO-2 clinical trial, select laboratory abnormalities occurring in ≥20% of patients included an increase in triglycerides, cholesterol, aspartate aminotransferase, alanine aminotransferase, bilirubin, activated partial thromboplastin, and alkaline phosphatase and a decrease in albumin, sodium, lymphocytes, platelets, and magnesium.

aGraded according to NCI CTCAE version 5.0.1
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: 409-444) and placebo (range: 195-216).1 

Manageable safety profile with FRUZAQLA1

Low rate of myelosuppression.
Low rate of myelosuppression1
  • Hematological abnormalities of any grade occurring in ≥20% of patients with either FRUZAQLA + BSC or placebo + BSC were decreased lymphocyte count (30% vs 32%), decreased platelet count (30% vs 4.7%), and increased activated partial thromboplastin time (21% vs 18%)
Dose interruptions or reductions due to ARs1,2
  • Dose interruptions: 47% with FRUZAQLA + BSC vs 27% with placebo + BSC
  • Dose reductions: 24% with FRUZAQLA + BSC vs 4% with placebo + BSC
Low rate of discontinuation.
Low rate of discontinuations due to ARs1,2
  • 20% with FRUZAQLA + BSC vs 21% for placebo + BSC

FRESCO-2 Efficacy Results

Learn about the efficacy results from FRESCO-2, a global, double-blind, placebo-controlled study with a heterogenous patient population.

FRESCO Safety Profile

Discover the safety profile of FRUZAQLA from the FRESCO clinical trial.

ARs=adverse reactions; BSC=best supportive care; VEGF=Vascular endothelial growth factor; VEGFR=Vascular endothelial growth factor receptor.