AstraZeneca has voluntarily withdrawn Imfinzi’s (durvalumab’s) indication for adults with locally advanced or metastatic bladder cancer following the confirmatory DANUBE trial’s inability to meet its primary end points.1

On May 1, 2017, the FDA awarded the PD-L1 inhibitor an accelerated approval for use in patients with locally advanced or metastatic disease who experienced disease progression during or after treatment with platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy. The conditional approval was based on efficacy data from the phase 1/2 single-arm Study 1108 trial (NCT01693562), but was contingent on the results of the phase 3 confirmatory DANUBE trial (NCT02516241).2

In a March 2020 press release,3 AstraZeneca announced that the DANUBE study, which compared Imfinzi monotherapy (n=346) with combination Imfinzi and tremelimumab (n=342) and standard-of-care chemotherapy (n=344), did not meet its overall survival (OS) primary outcomes measures. The coprimary end points were OS with single-agent Imfinzi vs chemotherapy in the study’s PD-L1-high subpopulation and OS with Imfinzi/tremelimumab vs chemotherapy, regardless of PD-L1 expression status.4

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The decision to withdrawal Imfinzi’s indication in the bladder cancer space was made in conjunction with the Food and Drug Administration (FDA), reports AstraZeneca.1 Imfinzi presently holds indications in the stage III non-small cell lung cancer and frontline extensive-stage small lung cancer settings.5


  1. Voluntary withdrawal of Imfinzi indication in advanced bladder cancer in the US. [press release]. AstraZeneca; February 22, 2021.
  2. Durvalumab (Imfinzi). FDA. May 1, 2017. Accessed February 22, 2021.
  3. Update on phase III DANUBE trial for Imfinzi and tremelimumab in unresectable, stage IV bladder cancer. [press release]. AstraZeneca; March 6, 2020.
  4. Powles T, van der Heijden MS, Castellano D, et al; DANUBE study investigators. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2020;21(12):1574-1588. doi:10.1016/S1470-2045(20)30541-6
  5. Imfinzi [package insert]. Cambridge, UK: AstraZeneca; 2020.