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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胃腺癌第一三共Enhertu抗体药物偶联物ENHERTUENHERTU（FAM-trastuzumab deruxtecan-nxki）
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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

    #Enhertu#

    0

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    2021-03-11 bugit

    #FDA批准#

    0

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    2021-01-20 xuruicheng

    #胃腺癌#

    0

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    2021-01-20 10518098zz

    #美国FDA#

    0

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