美国FDA批准阿斯利康和第一三共制药的Enhertu用于胃腺癌

2021-01-18 Allan MedSci原创

FDA近日表示,已扩大阿斯利康和第一三共的Enhertu(fam-trastuzumab deruxtecan-nxki)的适应症范围。

FDA近日表示,已扩大阿斯利康和第一三共的Enhertu(fam-trastuzumab deruxtecan-nxki)的适应症范围,以包括先前已接受过曲妥珠单抗治疗的局部晚期或转移性HER2阳性胃或胃食管(GEJ)腺癌。FDA于2019年底批准了抗体-药物偶联物Enhertu,允许其治疗先前接受过至少两种抗HER2的HER2阳性乳腺癌

最新的批准得到了II期DESTINY-Gastric01试验的数据支持,该试验涉及126例HER2阳性的局部晚期或转移性胃癌或胃食管腺癌患者,这些患者至少经过了两种先前的治疗方案,包括曲妥珠单抗、氟嘧啶和含铂类的化疗。

去年在美国临床肿瘤学会(ASCO)年会上发表的详细研究结果表明,在Enhertu治疗的患者中,客观缓解率(ORR)显著高于接受研究者选择的化疗的患者(42.9% vs. 12.5%)。Enhertu组患者的中位总生存期为12.5个月,而对照组为8.4个月。Enhertu组患者的中位无进展生存期分别为5.6个月,而对照组为3.5个月。 

 

原始出处:

https://www.firstwordpharma.com/node/1792013?tsid=4

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    2021-03-15 lhlxtx
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    2021-03-11 bugit
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