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Fruquintinib

Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.

IDDRUG-FRUQUINTINIB
TypeMédicament
Alias
ÉluminationFruzaqlaHMPL-013Фруквінтиніб
Étatreviewed 2026-04-27 | pending_clinical_signoff
MaladiesDIS-CRC
SourcesSRC-ESMO-COLON-2024 SRC-NCCN-COLON-2025

Faits sur les drogues

CatégorieInhibiteur de la tyrosine kinase VEGFR 1/2/3 par voie orale hautement sélective
MécanismeHighly selective ATP-competitive small-molecule TKI of vascular endothelial growth factor receptors 1, 2, and 3 (VEGFR-1/2/3), with sub-nanomolar in-vitro potency and minimal off-target inhibition (negligible activity vs FGFR, PDGFR, KIT, RET) — the selectivity profile is intentionally narrow to improve tolerability vs multikinase TKIs (regorafenib, sorafenib). Blocks VEGF-driven angiogenesis and lymphangiogenesis in the tumor microenvironment; no direct antiproliferative effect on tumor cells. Pivotal evidence FRESCO-2 (multinational, Western mCRC, refractory after chemo + anti-VEGF + anti-EGFR if RAS-WT, ± TAS-102 / regorafenib): fruquintinib vs placebo + best supportive care, mOS 7.4 vs 4.8 mo HR 0.66, mPFS 3.7 vs 1.8 mo HR 0.32. FDA approval Nov 2023. Original China approval 2018 (Elunate, FRESCO trial).
Dose typique5 mg PO once daily on a 3-weeks-on / 1-week-off schedule (28-day cycle), with or without food, until progression / unacceptable toxicity. Dose level -1 = 4 mg daily; -2 = 3 mg daily; permanent discontinuation if recurrent G3-4 at -2. Hold for hypertensive crisis, G3-4 hand-foot syndrome, G3-4 proteinuria, GI perforation / fistula, or severe hemorrhage. Stop 2 weeks pre-elective surgery and resume only after wound healing (≥2 weeks post-op typically). No formal renal adjustment for CrCl ≥30; not studied in severe hepatic impairment.
Ukraine enregistréeFaux
NSZU rembourséFaux
Ukraine vérifiée pour la dernière fois2026-04-27

Notes

Late-line refractory mCRC option alongside regorafenib and trifluridine/tipiracil (TAS-102) ± bevacizumab. Cross-trial comparison suggests numerically better tolerability than regorafenib (less HFS, less LFT elevation, more straightforward HTN management). FRESCO-2 enrolled patients post all-major-classes including TAS-102 / regorafenib — true salvage population. Baseline workup: BP, urinalysis (UPCR), LFTs, CBC, TSH, ECG, pregnancy test. Monitor BP weekly first 6 weeks then monthly, urinalysis monthly, LFTs monthly, TSH q3 months. Hold for SBP >160/100 — escalate antihypertensives (ACE-i / ARB first then CCB). Hold ≥2 weeks before elective surgery; resume only after full wound healing (typically ≥2 weeks post-op). UA access via EAP / self-pay; not on НСЗУ.

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