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On February 22, AstraZeneca announced the voluntary withdrawal of Imfinzi (durvalumab) in the United States for the indications of previously treated adults with locally advanced or metastatic bladder cancer.
On May 1, 2017, the FDA accelerated the approval of Imfinzi for the first time on the market based on the response rate and response duration data of a Phase I/II Study 1108 study (evaluating the efficacy and safety of Imfinzi on solid tumors) for the first time.
In March 2020, the results of the confirmatory phase III DANUBE study were announced.
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, said: “In the past few years, the science of tumor immunotherapy has made a lot of progress, providing patients with many treatment options.
Imfinzi was previously approved for second-line treatment of bladder cancer in 18 countries.
Prior to this, a total of 7 PD-1/PD-L1 drugs have successively won the marketing eligibility for bladder cancer indications, followed by atelizumab (Roche, 2016/5/18) and nivolumab ( BMS, 2017/2/2), Avermuzumab (Merck/Pfizer, 2017/5/9), Duvalizumab (AZ, 2017/5/1), Pembrolizumab (MSD) , 2017/5/18), Tilelizumab (BeiGene, 2020/4/10).
Imfinzi has found its own foothold in the PD1/PD-L1 circuit because of its outstanding performance in the subdivision indications of NSCLC in stage III.
