US FDA approves Durvalumab for advanced bladder cancer


In the past, advanced bladder cancer treatment has been confined to surgery, radiation therapy and chemotherapy, creating a need for additional treatment options. Immunotherapeutic agents have been approved for some cancer types, including the recent approval of the anti-PD-L1 antibody Atezolizumab for advanced bladder cancer. Similar to Atezolizumab, Durvalumab is a PD-L1 checkpoint inhibitor that, by binding to PD-L1, induces an immune response to kill cancer cells. Based on the results of Study 1108, the US FDA has now approved Durvalumab for the treatment of advanced bladder cancer. Study 1108 is a single-arm phase I/II trial that recruited 182 patients with locally advanced or metastatic bladder cancer who experienced treatment failure upon platinum-based chemotherapy. The objective response rate (ORR) was 17 %, however patients with high PD-L1 expression had a much higher response rate than patients with low PD-L1 expression (26.3% vs 4.1%). Among responders, 26 partial responses and five complete responses were observed. In conclusion, Durvalumab will become a promising new treatment option for patients with advanced bladder cancer.

Cancer Network:

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