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FDA approves Balversa for urothelial carcinoma with FGFR genetic alterations

Janssen Pharmaceuticals said Balversa (erdafitinib) received accelerated approval from FDA for the treatment of adults with locally advanced or metastatic urothelial carcinoma which has susceptible fibroblast growth factor receptor 3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.