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Erdafitinib FDA approved for the treatment of metastatic urothelial carcinoma

On 12 April 2019, the FDA granted accelerated approval to erdafitinib (Balversa®, Janssen) for the treatment of locally advanced or metastatic urothelial cell carcinoma (mUCC) progressed during or following a platinum-containing regimen, including progression within 12 months of (neo)adjuvant platinum-based chemotherapy, and whose tumours harbour susceptible fibroblast growth factor receptor (FGFR) 3 or FGFR2 genetic alterations as determined by the FDA approved companion diagnostic (CDx), the therascreen® FGFR RGQ RT-PCR Kit by Qiagen.