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News From the Food and Drug Administration
May 21, 2019

Precision Approach to Bladder Cancer

JAMA. 2019;321(19):1862. doi:10.1001/jama.2019.5751

The first fibroblast growth factor receptor (FGFR) kinase inhibitor recently received FDA approval for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC), the most common form of bladder cancer.

Erdafitinib, marketed as Balversa, is intended for patients with mUC whose tumors have altered FGFR2 or FGFR3 genes and progressed despite chemotherapy. A companion diagnostic test that detects FGFR mutations or fusions—previously developed to select patients suitable for targeted lung cancer treatment—gained simultaneous FDA approval for use with erdafitinib.