AstraZeneca Withdraws Imfinzi’s Bladder Cancer Indication

AstraZeneca (AZ) has voluntarily withdrawn the bladder cancer indication for its immunotherapy drug Imfinzi (durvalumab) in the U.S. after its late-stage trial failed to meet its primary endpoints.

The human monoclonal antibody was previously granted Accelerated Approval by the FDA, based on promising tumor response rates and duration of response data from a phase 1/2 trial that evaluated the drug’s safety and efficacy in advanced solid tumors — including previously treated bladder cancer. However, results from AZ’s phase 3 trial failed to meet primary endpoints as required to keep its approval for the drug for previously treated adults with locally advanced or metastatic bladder cancer.

“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,” said Dave Fredrickson, executive vice president of AZ’s oncology business unit.