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AstraZeneca withdraws Imfinzi indication for advanced bladder cancer in US
12 days ago - By Healio
AstraZeneca voluntarily withdrew durvalumab's indication for treatment of adults with locally advanced or metastatic bladder cancer.
The company made the decision in consultation with FDA after a phase 3 trial of the agent in this setting failed to meet its primary endpoints.
The FDA granted accelerated approval to durvalumab - a human monoclonal antibody that binds to PD-L1 - in May 2017 based on tumor response rates and response duration data from Study 1108, a phase 1/phase 2 trial that assessed the efficacy and safety of the agent for patients with
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