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AstraZeneca withdraws Imfinzi's advanced bladder cancer indication in the U.S.

 Last Update: 2021-03-19
 Source: Internet
 Author: User

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AstraZeneca recently announced that in the United States, AstraZeneca voluntarily withdrew its immunotherapy Imfinzi indications for the treatment of advanced bladder cancer.

immunity

After May 2017, showed promising tumor response rate and remission advanced solid tumors in phase II study data I /, the US Food and Drug Administration Administration ( the FDA ) approved Imfinzi (durvalumab) in patients with advanced bladder cancer.

Manage FDA

The approval of Imfinzi in this indication depends on the positive results of the Phase III DANUBE trial.

For patients with tumor cells and/or tumor infiltrating immune cells with high expression (≥25%) PD-L1, compared with standard treatment, Imfinzi monotherapy did not achieve the primary endpoint of improving overall survival (OS).

Compared with standard treatment, Imfinzi monotherapy did not achieve the primary endpoint of improving overall survival (OS).

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