Safety Profile
In FRESCO-2, the majority of adverse events (AEs) with Fruzaqla were manageable and predictable1-3
Serious AEs(SAE) were reported at similar rates among patients treated with Fruzaqla + BSC (n=172; 38 %) compared to those treated with placebo + BSC (n=88; 38 %).
The percentage of ≥ Grade 3 SAEs: Fruzaqla: 36% vs Placebo: 37%.
Most frequent (≥2 %) Grade 3 or worse serious adverse events with Fruzaqla +BSC compared with placebo+BSC were pneumonia (2 % vs <1 %) and abdominal pain (2 % vs 1 %).
*Predictable refers to AEs consistent with inhibition of VEGF and VEGFR3
Despite predictability, individual patient experiences may vary
** Hand-foot-synrome included in dermatological toxicity
Adapted from Dasari et al., 2023
.▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
References:
1. Fruzaqla EU Summary of Product Characteristics, latest approved version
2. Dasari A, et al. FRESCO-2 study investigators. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023;402(10395):41-53.
3. National Cancer Institute, National Institutes of Health. Angiogenesis inhibitors. https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/angiogenesis-inhibitors-fact-sheet (last consulted May 2025)
Abbreviations:
BSC: Best Supportive Care
AE: Adverse Events
SAE: Serious Adverse Events
VEGF: Vascular Endothelial Growth Factor
VEGFR: Vascular Endothelial Growth Factor Receptor
TEAE: Treatment Emergent Adverse Event
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