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FDA Grants Accelerated Approval to Erdafitinib for Metastatic Urothelial Carcinoma

Oncology Practice Insider

On April 12, 2019, the Food and Drug Administration granted accelerated approval to erdafitinib (BALVERSA, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Read more.