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Indications of Balversa

Balversa is indicated for the treatment of adult patients with locally advanced or metastatic  urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed  on or after at least one line of prior systemic therapy.  Select patients for therapy based on an FDA-approved companion diagnostic for Balversa.

Limitations of Use

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.

from FDA,2024.01

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