AZ withdraws Imfinzi indication

Country

United Kingdom

AstraZeneca Plc has voluntary withdrawn a bladder cancer indication for its checkpoint inhibitor Imfinzi (durvalumab) in the US, which was given an accelerated approval in 2017 but failed to show the required efficacy in a follow-up study. The Food and Drug Administration awards accelerated approvals to certain drugs, based on surrogate endpoints, but confirmation of clinical benefit needs to be verified in subsequent trials.