默克的PD-1单抗Keytruda获得国内非小细胞肺癌适应症的第三次批准

2019-12-02 不详 MedSci原创

默克(Merck)的重磅药物PD-1单抗Keytruda在不到一年的时间内就获得了国内非小细胞肺癌(NSCLC)治疗的第三项一线批准。

默克(Merck)的重磅药物PD-1单抗Keytruda在不到一年的时间内就获得了国内非小细胞肺癌NSCLC)治疗的第三项一线批准。

国家药品监督管理局(NMPA)的此次批准是基于KEYNOTE-407 3期研究的结果。该研究调查了Keytruda(pembrolizumab)与化疗(卡铂和紫杉醇)联合用于转移性鳞状NSCLC的一线治疗。

数据表明,与单独化疗相比,Keytruda组合在NSCLC患者中显示出总体生存率和无进展生存率的统计学显着改善。Keytruda联合化疗的组合使死亡风险降低了36%,疾病进展或死亡的风险降低了44%。

默克肿瘤临床研究副总裁Jonathan Cheng表示:"这项批准扩大了我们目前在中国的肺癌适应症,将KEYTRUDA与化疗联合用于鳞状细胞癌患者,这是一种特别难以治疗的肺癌。"

在中国,肺癌是导致癌症死亡的主要原因,每年在中国诊断出78.7万例新肺癌病例,并导致631000多例死亡。NSCLC是最常见的肺癌类型,占所有新病例的85%。

除了获得NSCLC的批准外,Keytruda还成为该类别中首个在中国批准用于治疗晚期黑素瘤的药物。

原始出处:


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