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Durvalumab Indication Withdrawn in Advanced Bladder Cancer in the United States

By: JNCCN 360 Staff
Posted: Thursday, February 25, 2021

On February 22, AstraZeneca announced the voluntary withdrawal of the PD-L1 inhibitor durvalumab (Imfinzi) indication in the United States for previously treated adults with locally advanced or metastatic bladder cancer. This decision was made in consultation with the U.S. Food and Drug Administration (FDA). This withdrawal does not impact the indication outside of the United States, nor does it impact other approval indications of durvalumab outside or within the United States (eg, in unresectable, stage III non–small cell lung cancer and extensive-stage small lung cancer).

In May 2017, durvalumab was granted accelerated approval in the United States based on tumor response rates and duration of response data from Study 1108, a phase I/II trial that evaluated its safety and efficacy in advanced solid tumors, including previously treated bladder cancer. Continued approval was contingent on results from the phase III DANUBE trial in the first-line metastatic bladder cancer setting, which did not meet its primary endpoints in 2020. The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet postmarketing requirements, as part of a broader industry-wide evaluation.

Patients with metastatic bladder cancer currently being treated with durvalumab should consult with their health-care provider regarding their ongoing care.



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