SUMMARY  

• THOR (BLC3001/NCT03390504) is an ongoing, phase 3, open-label, multicenter study evaluating the efficacy and safety of BALVERSA vs chemotherapy (docetaxel or vinflunine) or pembrolizumab in patients with metastatic or unresectable urothelial carcinoma (UC) and selected fibroblast growth factor receptor (FGFR) gene alterations that has progressed during or after 1 or 2 prior lines of therapy.^1,2  
  • Patients enrolled in the study were required to have adequate renal function described as: creatinine clearance ≥30 mL/min/1.73 m² either directly measured via 24-hour urine collection or calculated using Cockroft-Gault formula.³ 
• BLC2001 (NCT02365597) is a phase 2, multicenter, open-label study in adult patients with locally advanced and unresectable or metastatic UC and prespecified FGFR genetic alterations (FGFR3 mutation or FGFR2/3 fusion) with disease progression during or following ≥1 line of prior systemic chemotherapy or within 12 months of receiving neoadjuvant or adjuvant chemotherapy, or were chemotherapy-naïve due to cisplatin ineligibility. Efficacy and safety results are described for patients who received a starting dose of BALVERSA 8 mg orally once daily (N=99).^4,5
  • Patients enrolled in the study were required to have adequate renal function described as: creatinine clearance ≥40 mL/min/1.73 m² either directly measured via 24-hour urine collection or calculated using Cockroft-Gault formula.⁶
• No clinically meaningful trends in the pharmacokinetics (PK) of erdafitinib were observed based on mild (estimated glomerular filtration rate [eGFR; using modification of diet in renal disease equation] 60-89 mL/min/1.73 m²) or moderate (eGFR 30-59 mL/min/ 1.73 m²) renal impairment. No dose adjustment is required for patients with mild or moderate renal impairment based on population PK analyses.⁷
• A population PK model was developed using data pooled from 6 clinical studies (3 in healthy volunteers and 3 in patients with cancer) to characterize total and free plasma concentrations of erdafitinib following single and multiple-dose administration, to quantify the inter- and intraindividual variability in erdafitinib PK, and to understand clinically relevant covariates (N=373). Renal impairment was identified as a statistically significant covariate of apparent clearance of free erdafitinib (CL_free/F; +25% and +27% change for mild and moderate renal impairment relative to normal function, respectively).⁸
• Limited data are available in patients with severe renal impairment.⁷

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 11 February 2025.