Erdafitinib
[6] In the United Statest, erdafitinib is indicated for the treatment of adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.[3] In April 2019, erdafitinib was granted approval by the US Food and Drug Administration (FDA) for treatment of metastatic or locally advanced bladder cancer with an FGFR3 or FGFR2 alteration that has progressed beyond traditional platinum-based therapies, subject to a confirmatory trial.[11] In January 2024, the FDA approved erdafitinib for adults with locally advanced or metastatic urothelial carcinoma 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.[7] In January 2024, the FDA approved erdafitinib for adults with locally advanced or metastatic urothelial carcinoma 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.[12] Efficacy was evaluated in Study BLC3001 Cohort 1, a randomized, open-label trial of 266 participants with metastatic urothelial carcinoma harboring selected FGFR3 alterations who had received 1-2 prior systemic treatments, including a PD-1 or PD-L1 inhibitor.