SUMMARY  

• BLC2001 is a phase 2, multicenter, open-label study of BALVERSA in patients with locally advanced and unresectable or metastatic urothelial carcinoma (UC) and prespecified fibroblast growth factor receptor (FGFR) genetic alterations (FGFR3 mutation or FGFR2/3 fusion) who had progressed 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 have been reported for patients who received a starting dose of BALVERSA 8 mg orally once daily (N=99).^1,2
  • Patients enrolled in the study were required to have adequate renal function described as: creatinine clearance ≥40 mL/min/1.73m² either directly measured via 24-hour urine collection or calculated using Cockroft-Gault.³
• 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.⁴
• 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).⁵
• The PK of erdafitinib in patients with severe renal impairment or renal impairment requiring dialysis is unknown.

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 07 March 2024.