阿斯利康将撤回Imfinzi在美国治疗晚期膀胱癌的适应症

2021-02-22 16:04

AstraZeneca to withdraw Imfinzi U.S. indication for advanced bladder cancer hav世界播

阿斯利康将撤回Imfinzi在美国治疗晚期膀胱癌的适应症hav世界播


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FILE PHOTO: The AstraZeneca office building in Brussels hav世界播

资料图:布鲁塞尔的阿斯利康办公楼hav世界播


(Reuters) - AstraZeneca will voluntarily withdraw the use of its cancer drug Imfinzi to treat advanced bladder cancer in the United States after it failed to meet post-approval requirements, the Anglo-Swedish drugmaker said on Monday. hav世界播

(路透社)-英国-瑞典制药商阿斯利康(AstraZeneca)周一表示,在未能满足批准后的要求后,该公司将自愿退出其抗癌药物Imfinzi在美国治疗晚期膀胱癌的使用。hav世界播


Imfinzi, mainly a lung cancer treatment, was granted accelerated approval for the bladder cancer indication in 2017, and the withdrawal does not impact markets outside the United States, the company said. hav世界播

Imfinzi主要用于肺癌治疗,该公司表示,2017年,Imfinzi获得了膀胱癌适应症的加速批准,撤回不会影响美国以外的市场。hav世界播


The treatment failed the main goal of a late-state trial last year and the decision was based in consultation with U.S. authorities, the company said. hav世界播

该公司表示,这种治疗未能达到去年晚些时候进行的州试验的主要目标,这一决定是在与美国当局协商的基础上做出的。hav世界播


"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," Dave Fredrickson, executive vice president of the company's oncology business division, said in a statement. hav世界播

该公司肿瘤学业务部执行副总裁戴夫·弗雷德里克森(Dave Fredrickson)在一份声明中表示:“虽然之前治疗的转移性膀胱癌的撤退令人失望,但我们尊重FDA在建立加速审批途径时提出的原则。”hav世界播


Imfinzi belongs to the immunotherapy class of treatments that boost the body's own defences to fight cancer by using antibodies that block or bind to foreign substances in the body. hav世界播

Imfinzi属于免疫疗法的一类,这种疗法通过使用抗体来阻断或结合体内的异物来增强人体自身的防御能力,从而与癌症作斗争。hav世界播


AstraZeneca also said other U.S. indications for the drug, which brought in $2.04 billion in global revenue last year, were not affected by the withdrawal, adding that it was notifying healthcare providers of the update. hav世界播

阿斯利康还表示,该药在美国的其他适应症不受撤药的影响,并补充说,该公司正在通知医疗保健提供商这一更新。该药去年为全球带来了20.4亿美元的收入。hav世界播

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