Erdafitinib monotherapy (THOR cohort 1) — 2L+ FGFR2/3-altered metastatic urothelial carcinoma
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| Components | DRUG-ERDAFITINIB |
|---|
| ID | REG-ERDAFITINIB-UROTHELIAL-2L |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-NCCN-BLADDER-2025 |
Notes
THOR (Loriot NEJM 2023) phase 3, cohort 1: erdafitinib 8 mg PO daily (with up-titration to 9 mg if phosphate <5.5 mg/dL day 14) vs investigator-choice chemotherapy (docetaxel OR vinflunine) in metastatic urothelial carcinoma with selected FGFR2/3 alterations (mutation S249C / R248C / G370C / Y373C OR FGFR2/3 fusion), after ≥1 prior line including PD-(L)1 inhibitor (n=266; 136 erda vs 130 chemo). Met primary endpoint mOS 12.1 vs 7.8 mo (HR 0.64, p=0.005), mPFS 5.6 vs 2.7 mo (HR 0.58), ORR 35.3% vs 8.5%. THOR cohort 2 (erda vs pembrolizumab in PD-(L)1-naive) was negative and not used to support labeling. FDA converted accelerated to full approval Jan 2024 based on THOR cohort 1. Class toxicity: hyperphosphatemia (~76%), nail toxicity (~57%), stomatitis, central serous retinopathy (~25%, usually reversible). STUB pending Clinical Co-Lead sign-off. Trial source SRC-THOR-LORIOT-2023 not yet authored in KB; cited via NCCN-BLADDER-2025 (urothelial ESMO guideline not yet in KB either — flagged in commit body).
Used By
Indication
IND-UROTHELIAL-2L-ERDAFITINIB- IND-UROTHELIAL-2L-ERDAFITINIB