Policy & Regulation
AstraZeneca withdraws Imfinzi indication in advanced bladder cancer in US
22 February 2021 -

Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) said on Monday that it has voluntarily withdrawn the Imfinzi (durvalumab) indication in the United States for previously treated adult patients with locally advanced or metastatic bladder cancer.

This decision was made in consultation with the US Food and Drug Administration (FDA).

In May 2017, Imfinzi was granted accelerated approval in the US based on promising tumour response rates and duration of response data from Study 1108, a Phase I/II trial that evaluated the safety and efficacy of Imfinzi in advanced solid tumours, including previously treated bladder cancer. Continued approval was contingent on results from the DANUBE Phase III trial in the first-line metastatic bladder cancer setting, which did not meet its primary endpoints in 2020.

The withdrawal is in line with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements. It does not impact the indication outside the US and does not impact other approved Imfinzi indications within or outside the US, AstraZeneca noted.

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