Infigratinib
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| ID | DRUG-INFIGRATINIB |
|---|---|
| Art | Arzneimittel |
| Aliase | TruseltiqІнфіґратиніб |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Erkrankungen | DIS-CHOLANGIOCARCINOMA |
| Quellen | SRC-ESMO-BTC-2023 SRC-NCCN-HEPATOBILIARY |
Drug Facts
| Klasse | Selektiver oraler FGFR1/2/3-Tyrosinkinase-Inhibitor |
|---|---|
| Verfahren | Oral, ATP-competitive selective inhibitor of FGFR1, FGFR2, and FGFR3 (lower activity vs FGFR4). Mechanism shared with pemigatinib: reversible kinase inhibition; activity against fusion- and rearrangement-driven FGFR2 alterations dominant in intrahepatic cholangiocarcinoma. Pivotal CBGJ398X2204 Phase II (108 patients, FGFR2 fusion / rearrangement iCCA post ≥1 prior line including gem-cis) showed ORR 23.1%, mDOR 5.0 mo, mPFS 7.3 mo → FDA accelerated approval May 28, 2021. |
| Typische Dosierung | HISTORISCHE (nicht mehr vermarktet): 125 mg PO einmal täglich an den Tagen 1-21 eines 28-Tage-Zyklus (21 Tage an / 7 Tagen frei), bis zur Progression oder inakzeptable Toxizität. Nehmen Sie auf leeren Magen (≥ 1 h vor oder ≥ 2 h nach der Nahrung). Phosphatbinder + Diätphosphat-Restriktion Routine. Dosisänderungen für Hyperphosphatämie und okuläre Toxizität pro Etikett Tabelle. Hinweis: Truseltiq kommerziellen Abbruch angekündigt Aug 2022; diese Dosierung ist für Archival / Vergleichs-Test Referenz dokumentiert. |
| Ukraine registriert | Falsch |
| NSZU erstattet | Falsch |
| Ukraine zuletzt überprüft | 2026-04-29 |
Anmerkungen
Infigratinib (Truseltiq) was the SECOND FGFR-targeted therapy approved for FGFR2-altered cholangiocarcinoma (after pemigatinib in Apr 2020), with FDA accelerated approval May 28, 2021 based on CBGJ398X2204 Phase II (Javle JCO 2021). However, Helsinn / QED Therapeutics voluntarily discontinued commercial supply of Truseltiq in the US oncology indication in August-September 2022 — citing the competitive landscape (pemigatinib + futibatinib) and inability to complete the PROOF-301 confirmatory Phase III (1L vs gem-cis in FGFR2-fusion iCCA; enrollment failed, study terminated). Result: infigratinib is NO LONGER COMMERCIALLY AVAILABLE for cholangiocarcinoma. Documented in KB for historical / comparator-trial completeness; clinical recommendations for FGFR2-altered iCCA route to pemigatinib (1L preferred per FIGHT-302 pending readout) or futibatinib (covalent; retains activity against some pemigatinib-resistance variants). Class toxicity profile mirrored other FGFR TKIs (hyperphosphatemia, RPED, stomatitis, nail toxicity). Note: infigratinib (under brand Truseltiq) retains a separate FDA approval in achondroplasia (pediatric short-stature), an unrelated indication outside oncology scope...
Verwendet von
Therapieschema
REG-INFIGRATINIB-CHOLANGIO-2L- Infigratinib-Monotherapie (CBGJ398X2204) — 2L+ FGFR2-Fusionscholangiokarzinom (HISTORISCHES)