阿斯利康(AZN.US)“度伐利尤单抗”欧盟获批新适应症

智通财经
27 May

智通财经APP获悉,5月27日,阿斯利康(AZN.US)宣布 Imfinzi(度伐利尤单抗)已获得欧盟批准,具体适应症为:度伐利尤单抗联合吉西他滨和顺铂作为新辅助治疗,随后度伐利尤单抗作为根治性膀胱切除术后的辅助单药治疗,用于治疗肌层浸润性膀胱癌 (MIBC) 成年患者。

新闻稿指出,这是首个也是唯一一个针对肌层浸润性膀胱癌患者的围手术期免疫疗法。

此外,本次新适应症的获批是基于多中心、全球 III 期试验 NIAGARA 的结果。该试验旨在评估根治性膀胱切除术前后使用度伐利尤单抗对 MIBC 患者进行围手术期治疗的效果。

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