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全球BTK抑制剂亿珂®（伊布替尼）在中国获批

2017-10-17 佚名 MedSci

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2017年8月24日，全球首个口服BTK抑制剂亿珂？（伊布替尼）正式获得中国食品药品监督管理总局（CFDA）批准，用于治疗慢性淋巴细胞白血病及套细胞淋巴瘤患者。亿珂？（伊布替尼）曾四次被FDA授予突破性药物认定，获得国际奖项“盖伦奖”，截止目前全球85个国家获批超过65000名患者受益，未来将开启中国B细胞淋巴瘤治疗的新纪元！BTK抑制剂的发现发展之旅-新型靶向药物的诞生据报道，1999年合成了首

2017年8月24日，全球首个口服BTK抑制剂亿珂？（伊布替尼）正式获得中国食品药品监督管理总局（CFDA）批准，用于治疗慢性淋巴细胞白血病及套细胞淋巴瘤患者。亿珂？（伊布替尼）曾四次被FDA授予突破性药物认定，获得国际奖项“盖伦奖”，截止目前全球85个国家获批超过65000名患者受益，未来将开启中国B细胞淋巴瘤治疗的新纪元！

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BTK抑制剂的发现发展之旅-新型靶向药物的诞生

据报道，1999年合成了首个BTK抑制剂LFM-A13，但是遗憾的是，随后LFM-A13并未开展临床研究，不过在了解BTK抑制作用的机理下，美国塞莱拉基因公司药物化学教研室学者继续展开研究，最终合成了compound 4，并用两种方法证实了这类药物与BTK结合的不可逆性，ibrutinib就此诞生。

而后动物及人体外研究均提示PCI-32765与BTK活化位点不可逆结合，可获得满意疗效。2013年《J Clin Oncol》杂志公布了一项令人激动人心的结果，56例RR B细胞淋巴瘤或CLL患者接受口服ibrutinib升阶梯治疗，ibrutinib与BTK的cys481不可逆结合至少24h。患者OR率为60%，CR为16%4。因此，2013年开始获得FDA加速审批：2013.11MCL，2014.7CLL，2015.1WM，同时欧洲药物机构也批准了这些B细胞恶性肿瘤的药物治疗。

2012年发表于Blood的一项研究阐释了伊布替尼的作用机制：PCI-32765通过抑制BTK，抑制肿瘤细胞生存和增殖，抑制BCR调控的粘附，调节趋化因子调控的粘附和迁移。同时合理阐释了CLL患者接受伊布替尼治疗后出现的临床应答：可获得快速且持续的淋巴结病变缓解，伴随暂时停药后可逆的一过性淋巴细胞增多。

CLL/SLL和MCL疗效上历史性的突破

PCYC-1102/03研究

2013年首次发布在新英格兰医学杂志，纳入了101例R/R CLL患者，研究共随访5年发现，伊布替尼单药治疗患者ORR为89%，中位PFS为52个月，中位OS未达到，5年OS为57%。突破现有免疫化疗方案治疗RR CLL后PFS不到2年的局限。

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MCL-3001 RAY研究

发表Lancet杂志的一项伊布替尼研究，纳入了280例R/R MCL患者，随访3年，结果显示，伊布替尼单药治疗ORR为72%，中位PFS为15.6个月，中位OS为30.3个月。并且首次复发后使用，PFS可延长至25.4个月， OS 延长至42.1个月；

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可靠的安全性

在中国发起的以CLL/SLL亚洲患者为主的CLL 3002国际多中心Ⅲ期研究报告显示：伊布替尼对比利妥昔单抗显着提高ORR，中位随访18个月，伊布替尼PFS 74% vs 利妥昔单抗 PFS 11.9%，OS 伊布替尼 vs 利妥昔单抗79.8% vs57.6%，在显着提高PFS与OS的同时，伊布替尼治疗不良事件多为1或2级，3，4级非常罕见，无剂量相关性，每日一次的口服治疗也给患者带来了更好的生活质量。

相信亿珂？（伊布替尼）在中国获批定会为淋巴瘤患者带来全新的治疗选择与更高的生活质量，推动中国淋巴瘤治疗领域水平的提高。

如需了解更多淋巴瘤的前沿信息 请扫描二维码访问“淋巴瘤亿刻”网站。

淋巴瘤亿刻二维码.png

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    2018-05-07 jklm09

    #抑制剂#

    0

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    2017-10-19 wangbingxhy

    #亿珂#

    0

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    2017-10-19 hongbochen

    #伊布替尼#

    0

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    2017-10-19 zhixianchen

    #BTK抑制剂#

    0

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    2017-10-19 fengting7

    #BTK#

    0

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