After consulting with the Food and Drug Administration (FDA), AstraZeneca has decided to withdraw the indication for Imfinzi (durvalumab) in the United States (US) for the treatment of locally advanced or metastatic urothelial carcinoma in previously treated adults.

In 2017, the FDA granted accelerated approval to Imfinzi, a programmed death-ligand 1 (PD-L1) blocking antibody, for locally advanced or metastatic bladder cancer based on data from a phase 1/2 study ( NCT01693562), which showed promising tumor response rates and duration of response. However, results from the subsequent confirmatory phase 3 DANUBE trial ( NCT02516241) evaluating Imfinzi as a first-line treatment in a metastatic bladder cancer setting showed that it did not meet the primary end points in 2020.

The withdrawal of the Imfinzi indication does not affect its use outside the US, along with other FDA approved indications for Imfinzi. Patients with metastatic bladder cancer who are receiving Imfinzi should consult with their health care provider.

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According to the FDA’s accelerated approval program, a drug may be approved earlier if it is intended to treat a serious condition or fills an unmet need; the approval is based on a surrogate end point that is thought to predict clinical benefit. A confirmatory trial is then required to prove clinical benefit. If the confirmatory trial does not show clinical benefit, the Agency can take steps to remove the drug or indication.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “While the withdrawal in previously treated metastatic bladder cancer is disappointing, we respect the principles FDA set out when the accelerated approval pathway was founded and remain committed to bringing new and innovative options to patients.”


Voluntary withdrawal of Imfinzi indication in advanced bladder cancer in the US. [press release]. AstraZeneca; February 22, 2021. 

This article originally appeared on MPR