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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 a validated test for BALVERSA [see Patient Selection under Dosage & Administration and Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
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 [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
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