阿斯利康和第一三共制药的Enhertu在美国获批用于早期治疗乳腺癌

2022-05-09 Allan MedSci原创

与罗氏的 Kadcyla(曲妥珠单抗 emtansine)相比,Enhertu 在 HER2 阳性不可切除和/或转移性患者中将疾病进展或死亡风险降低了 72% 。

HER2 阳性乳腺癌是一种被称为人表皮生长因子受体 2(HER2)的蛋白质检测呈阳性的乳腺癌。这种蛋白质对癌细胞的生长有促进作用。HER2 阳性乳腺癌通常比其他类型的乳腺癌更具侵袭性。

阿斯利康(AstraZeneca)和第一三共(Daiichi Sankyo)近日宣布,FDA 已批准 Enhertu(曲妥珠单抗-deruxtecan)用于治疗患有不可切除或转移性 HER2 阳性乳腺癌患者。两家公司指出,该决定将抗体-药物偶联物 Enhertu 的适应症扩大到早期治疗线。

具体而言,Enhertu 已被批准用于治疗患有不可切除或转移性 HER2 阳性乳腺癌成人患者,这些患者在转移性环境中或在新辅助或辅助环境中接受过基于抗 HER2 的方案,并且在治疗期间或在完成治疗后六个月内出现疾病复发。阿斯利康肿瘤业务部门执行副总裁 Dave Fredrickson 说:“我们很高兴通过这项批准,美国的患者现在可以在治疗早期使用 Enhertu”。

最初的加速批准得到了单臂 II 期 DESTINY-Breast01 试验数据的支持,其中 Enhertu 组患者的总体缓解率为 60.3%,包括 4.3% 的完全缓解率和 56% 的部分缓解率。III 期 DESTINY-Breast03 研究的结果显示,与罗氏的 Kadcyla(曲妥珠单抗 emtansine)相比,Enhertu 在 HER2 阳性不可切除和/或转移性患者中将疾病进展或死亡风险降低了 72% 。

两家公司指出,新的批准是根据 FDA 的实时肿瘤学审查(RTOR)计划授予的,而该申请也通过 Orbis 项目进行评估,澳大利亚、巴西、加拿大、以色列和瑞士的监管机构通过 Orbis 项目进行合作审查。

 

原始出处:

https://firstwordpharma.com/story/5564019

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    2022-05-15 lhlxtx
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    2022-05-09 ms7000000160761892

    乳腺癌治疗新方法

    0

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    2022-05-09 病毒猎手

    #阿斯利康##第一三共#制药#乳腺癌#,三个关键词

    0

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超50万国人11年前瞻研究:喝奶致癌是真的?!其中每天多喝50g,这3种癌风险就多上升超10%!

BMC Med:中国成年人的乳制品消费量以及总癌症和特定部位癌症的风险:一项针对50万人的11年前瞻性研究。

拓展阅读

FDA授予Enhertu在肺癌中的优先审查权

如果获得批准,这将是 Enhertu 的第三种肿瘤适应症。

阿斯利康/第一三共的 Enhertu 在 HER2低表达的乳腺癌研究中取得成功

与医生选择的化疗相比,抗体药物偶联物 Enhertu(曲妥珠单抗-deruxtecan)显著改善了 HER2 低表达的不可切除和/或转移性乳腺癌患者的无进展生存期(PFS)和总生存期(OS)。

WCLC 2020:Datopotamab deruxtecan和Enhertu在晚期非小细胞肺癌患者中显示出有希望的临床活性

两种抗体药物偶联物(ADCs)对晚期NSCLC患者均具有令人鼓舞的疗效。

美国FDA批准阿斯利康和第一三共制药的Enhertu用于胃腺癌

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。

靶向HER2的抗体药物偶联物ENHERTU获得FDA授予突破性疗法称号,治疗HER2阳性转移性非小细胞肺癌

Enhertu已经获得了FDA授予针对HER2阳性乳腺癌、胃癌和非小细胞肺癌的突破性疗法称号。

FDA授予靶向HER2的抗体药物偶联物ENHERTU突破性疗法称号,以治疗HER2阳性转移性胃癌

与接受化疗相比,接受ENHERTU治疗后患者的客观应答率(ORR)和总体生存率(OS)具有统计学意义和临床意义的改善。