Locally advanced or metastatic urothelial carcinoma in patients who have disease progression with platinum-based chemotherapy
Human IgG1 kappa monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80, and therefore overcoming/preventing PD-L1-mediated inhibition/suppression of T-cell activation.
10 mg/kg IV q2wk. Continue until disease progression or unacceptable toxicity.
Approval was based on a single-arm trial of 182 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after prior platinum-containing chemotherapy. Overall response rate was 17%.
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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.