The European Medicines Agency (EMA) has accepted for review a filing made by the Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) for the tyrosine kinase inhibitor (TKI) Balversa (erdafitinib) as a treatment for locally advanced unresectable or metastatic urothelial carcinoma (UC) in adults with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations who do not respond to PD-1/L1 therapy. This move marks a significant step in addressing the unmet medical needs of patients with this specific type of bladder cancer, which is the most common form and accounts for up to 20% of metastatic UC cases driven by FGFR mutations.
Phase III Trial Results Support Filing
The submission is supported by interim efficacy and safety results from a Phase III trial that successfully met its primary endpoint, demonstrating a median overall survival (OS) of over 1 year. An independent committee recommended migrating the control group to Balversa therapy and stopping the study, highlighting the drug’s potential impact on patient outcomes.
Potential Impact on Urothelial Carcinoma Treatment
The acceptance of Janssen’s filing by the EMA signifies the potential for a new treatment option for patients with advanced urothelial carcinoma who have FGFR3 genetic alterations and do not respond to PD-1/L1 therapy. Balversa’s approval could significantly change the treatment landscape for this patient population, offering a targeted therapy approach to combat a disease with limited treatment options.-Fineline Info & Tech
