Infigratinib
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-INFIGRATINIB |
|---|---|
| Тип | Препарат |
| Синоніми | TruseltiqІнфіґратиніб |
| Статус | переглянуто 2026-04-29 | очікує клінічного підпису |
| Хвороби | DIS-CHOLANGIOCARCINOMA |
| Джерела | SRC-ESMO-BTC-2023 SRC-NCCN-HEPATOBILIARY |
Дані про препарат
| Клас | Selective oral FGFR1/2/3 tyrosine kinase inhibitor |
|---|---|
| Механізм дії | 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. |
| Типове дозування | HISTORICAL (no longer marketed): 125 mg PO once daily on days 1-21 of a 28-day cycle (21 days on / 7 days off), until progression or unacceptable toxicity. Take on empty stomach (≥1 h before or ≥2 h after food). Phosphate binders + dietary phosphate restriction routine. Dose modifications for hyperphosphatemia and ocular toxicity per label table. Note: Truseltiq commercial discontinuation announced Aug 2022; this dosing is documented for archival / comparator-trial reference only. |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-04-29 |
Нотатки
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...
Де використовується
Regimens
REG-INFIGRATINIB-CHOLANGIO-2L- Infigratinib monotherapy (CBGJ398X2204) — 2L+ FGFR2-fusion cholangiocarcinoma (HISTORICAL)