Treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
Approved under accelerated approval based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
Enfortumab vedotin is an anti-Nectin-4 IgG1 kappa monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E via a protease-cleavable maleimidocaproyl valine-citrulline linker.
Enfortumab vedotin-ejfv is biosimilar
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