AstraZeneca announced it has voluntarily withdrawn the indication for durvalumab (Imfinzi) in previously treated adult patients with locally advanced or metastatic bladder cancer in the United States.1
Health care providers are currently being notified of this update and patients with metastatic bladder cancer being treated with durvalumab should consult with their individual provider regarding their care moving forward.
Importantly, this decision was made in consultation with the FDA and the withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements, as part of a broader industry-wide evaluation. However, this withdrawal does not affect indications outside the United States and does not impact other approved indications for durvalumab within or outside the United States.
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