J&J says FDA grants full approval for Balversa for mUC with genetic alterations

Johnson & Johnson announced that the U.S. Food and Drug Administration approved a supplemental New Drug Application, or sNDA, for Balversa for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma, or mUC, with susceptible fibroblast growth factor receptor 3 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. “This FDA action converts the April 2019 accelerated approval of Balversa to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study. Balversa is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations,” J&J stated.