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BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has: susceptible FGFR3 or FGFR2 genetic alterations; and progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
Select patients for therapy based on a validated companion diagnostic for BALVERSA [see Patient Selection under Dosage & Administration; Pharmacology: Pharmacodynamics: Clinical Studies: Urothelial Carcinoma with Susceptible FGFR Genetic Alterations under Actions].
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