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FDA Approves Janssen's BALVERSA® for Patients with Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

January 22, 2024 2:09 PM | Katy Monaco (Administrator)

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.  Read More


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