The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an indication extension application to the US Food and Drug Administration (FDA) for its FGFR kinase inhibitor Balversa (erdafitinib). The application seeks to expand the use of Balversa as a treatment for locally advanced or metastatic urothelial carcinoma (mUC) in adults with susceptible FGFR3 mutations and disease progression after at least one line of PD-1/L1 therapy. Additionally, the filing aims to support the 2019 accelerated approval for locally advanced or mUC with susceptible FGFR3 or FGFR2 mutations that have progressed after at least one line of platinum-containing chemotherapy.
Supporting Data from Late-Stage Trial
The company has backed its application with interim results from an ongoing late-stage trial. The trial, which has been recommended to be stopped after meeting its primary endpoint, achieved a median overall survival (OS) of over 1 year. This significant milestone indicates the potential efficacy of Balversa in treating patients with urothelial carcinoma who have exhausted other treatment options.
Implications for Urothelial Carcinoma Treatment
The submission of the indication extension application for Balversa reflects Janssen’s commitment to expanding treatment options for patients with urothelial carcinoma. If approved, Balversa could provide a new therapeutic approach for patients with FGFR3 or FGFR2 mutations, offering hope for those facing limited treatment options.-Fineline Info & Tech
