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February 23, 2021AstraZeneca Withdraws Imfinzi Bladder Cancer Indication
February 22, 2021 – AstraZeneca, the manufacturer of Imfinzi (durvalumab), has voluntarily withdrawn the drug’s indication to treat locally advanced or metastatic bladder cancer in adults. The indication received accelerated approval from the U.S. FDA in 2017.
Accelerated approval provides a mechanism by which the FDA can make drugs available to patients more quickly, based on early trial results. Continued approval in this instance is typically contingent upon demonstration of clinical benefit in confirmatory clinical trials. Imfinzi failed to meet primary endpoints in the DANUBE Phase III trial, which would have supported its continued approval to treat bladder cancer.
Although Imfinzi has lost its bladder cancer indication, it is still indicated to treat Stage III non-small cell lung cancer (NSCLC) and extensive-stage small cell lung cancer (ES-SCLC). The drug received FDA approval for NSCLC in 2018 and for ES-SCLC in 2020.