Erdafitinib

Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.

ID	`DRUG-ERDAFITINIB`
Тип	Препарат
Синоніми	BalversaЕрдафітініб
Статус	переглянуто 2026-04-29 \| очікує клінічного підпису
Хвороби	`DIS-UROTHELIAL`
Джерела	`SRC-CIVIC` `SRC-NCCN-BLADDER-2025`

Дані про препарат

Клас	Pan-FGFR (FGFR1-4) tyrosine kinase inhibitor
Механізм дії	Oral, ATP-competitive pan-FGFR (1, 2, 3, 4) kinase inhibitor that selectively targets tumors driven by FGFR2/FGFR3 activating mutations or fusions. Pivotal BLC2001 Phase II (87 patients with locally advanced/metastatic urothelial carcinoma harboring FGFR2/3 mutations or fusions, post-platinum) showed ORR 40% (CR 3%, PR 37%), mDOR 5.6 months → FDA accelerated approval Apr 2019. Confirmatory THOR Phase III (Cohort 1: erdafitinib vs investigator-choice chemotherapy in post-platinum + post-IO 2L/3L FGFR-altered urothelial) demonstrated mOS 12.1 vs 7.8 months (HR 0.64, p=0.005) → FDA full approval Jan 2024 with simultaneous restriction of indication to post-platinum + post-PD-1/L1 setting (THOR Cohort 2 erdafitinib vs pembrolizumab in IO-naive 2L was negative — pembrolizumab preferred when ICI-naive).
Типове дозування	Starting dose 8 mg PO once daily continuously; uptitrate to 9 mg QD on day 14-21 if serum phosphate <5.5 mg/dL AND no significant ocular or other AEs (achieves target steady-state phosphate ≥5.5 mg/dL, associated with improved efficacy in BLC2001/THOR). Dose modifications for hyperphosphatemia: hold for phosphate >7.0 mg/dL despite dietary restriction + phosphate binders; reduce or discontinue for ocular AEs (CSR, retinal detachment) detected on monthly OCT. Potent CYP3A4/2C9 substrate — adjust dose with strong inhibitors/inducers per label table.
Зареєстровано в Україні	False
Відшкодовується НСЗУ	False
Остання перевірка для України	2026-04-29

Нотатки

Erdafitinib is the first FGFR-targeted therapy in genitourinary oncology and remains the only oral targeted agent for FGFR2/3-altered metastatic urothelial carcinoma. NCCN-Bladder 2025 lists erdafitinib category 1 in 2L+ FGFR-altered after platinum + PD-1/L1; therascreen FGFR RGQ RT-PCR is the FDA-cleared companion diagnostic, but NGS panels (FoundationOne, MSK-IMPACT, Caris) detecting the same alleles + fusions are clinically interchangeable. Phosphate management requires close coordination — target serum phosphate 5.5-7.0 mg/dL for efficacy without crossing the soft-tissue mineralization threshold. Monthly OCT for first 4 months is mandatory due to CSR risk. THOR Cohort 2 (erdafitinib vs pembrolizumab in IO-naive 2L) was negative — sequencing is platinum → IO → erdafitinib, not IO-substitution. Missing source IDs to flag for follow-up: SRC-BLC2001, SRC-THOR, SRC-FDA-BALVERSA not yet authored.

Де використовується

Regimens

REG-ERDAFITINIB-UROTHELIAL-2L - Erdafitinib monotherapy (THOR cohort 1) — 2L+ FGFR2/3-altered metastatic urothelial carci...