FDA Approves Advanced Bladder Cancer

FDA Approves Advanced Bladder Cancer

fdaoksimmunoThe FDA today granted accelerated approval for atezolizumab (Tecentriq) for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) in patients who have disease progression during or after platinum-based chemotherapy, or whose disease worsened within 12 months of platinum-based chemotherapy before or after surgery.

Atezolizumab is a monoclonal antibody that binds with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. The drug blocks interactions with both PD-1 and B7.1 receptors to enable the activation of T cells.

The approval was based on an open-label, multicenter, 2 cohort phase 2 study that evaluated the safety and efficiency of Tecentriq in patients with locally advanced or mUC, regardless of PD-L1 expression.

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