- The company reported the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for prior treated adult patients with LA or metastatic bladder cancer. The withdrawal was made in consultation with the US FDA
- The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements
- In May’2017, Imfinzi has received accelerated approval in the US based on Study 1108 while the continued approval was contingent on results from the P-III DANUBE study in the 1L metastatic bladder cancer setting, which did not meet its 1EPs in 2020
Click here to read full press release/ article | Ref: AstraZeneca | Image: Healthline
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