BALVERSA® (Erdafitinib)

The FDA on January 19, 2024, approved BALVERSA® for adult patients with locally advanced or metastatic Urothelial Carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy. BALVERSA® is a product of Janssen Biotech.