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 hepatic function described as: total bilirubin ≤1.5x institutional upper limit of normal (ULN), unless known to have Gilbert’s disease; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5x institutional ULN; and albumin ≥2.0 g/dL.³
  • Exclusion criteria included known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients with a history of hepatitis C infection but negative hepatitis C virus polymerase chain reaction (PCR) test and subjects with hepatitis B with positive hepatitis B surface antibody were allowed.³
• No clinically meaningful differences in the pharmacokinetics (PK) of erdafitinib were observed with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment based on population PK analysis. No dose adjustment is required for patients with mild or moderate hepatic 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). The analysis demonstrated that mild hepatic impairment was not a significant covariate of erdafitinib exposure.⁵
• Limited data are available in patients with severe hepatic impairment.⁴

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.