The FDA granted accelerated approval to erdafitinib (Balversa, Janssen) for the treatment of adults with locally advanced or metastatic urothelial cancer with susceptible fibroblast growth factor receptor (FGFR) alterations that has progressed during or after platinum-containing chemotherapy. Patients should be selected for therapy using an FDA-approved companion diagnostic device.
FGFR alterations are present in approximately one in five patients with recurrent and refractory urothelial