Erdafitinib & Bladder Cancer (FGFR m)

FDA status:
In the context of Erdafitinib & Bladder Cancer (FGFR m), on January 19, 2024, the Food and Drug Administration approved erdafitinib 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. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy (2).

Clinical data:

The open-label, clinical phase II treatment trial, identified as NCT02365597, demo…