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日本厚生劳动省批准CAR-T细胞疗法Breyanzi治疗DLBCL和滤泡性淋巴瘤

2021-03-29 Allan MedSci原创

DLBCL滤泡性淋巴瘤NHLBreyanzi
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该批准基于TRANSCEND NHL 001试验在R / R B细胞非霍奇金淋巴瘤（NHL）患者中的功效和安全性数据。

大B细胞淋巴瘤包括几种疾病类型，包括弥漫性大B细胞淋巴瘤（DLBCL）。DLBCL是日本最常见的非霍奇金淋巴瘤（NHL），占所有B细胞肿瘤的30-40％，在60多岁的人群中尤为普遍。目前尚无既定的护理标准治疗复发难治DLBCL，强调了对该疾病领域新疗法的需求。

百时美施贵宝近日宣布，日本厚生劳动省（MHLW）批准了Breyanzi（lisocabtagene maraleucel，liso-cel），这是一种靶向CD19的嵌合抗原受体（CAR）T细胞疗法，用于治疗复发或难治性患者（R / R）大B细胞淋巴瘤和R / R滤泡性淋巴瘤。

该批准基于TRANSCEND NHL 001试验在R / R B细胞非霍奇金淋巴瘤（NHL）患者中的功效和安全性数据，以及TRANSCEND WORLD试验在R / R滤泡性淋巴瘤患者中的有效性和安全性数据。

百时美施贵宝公司总裁兼首席执行官Jean-Christophe Barland表示：“我很高兴我们在日本获得Breyanzi的监管批准，这将使我们能够为复发或难治性大B细胞淋巴瘤和滤泡性淋巴瘤患者提供新的治疗选择”。

 

原始出处：

https://www.firstwordpharma.com/node/1813341?tsid=4

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    2021-12-29 仁者大医

    #CAR-#

    0

  2. 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    2021-06-08 ms7258648636991762

    #LBCL#

    0

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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478060, encodeId=84f314e806047, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Wed Mar 31 00:16:57 CST 2021, time=2021-03-31, status=1, ipAttribution=)]
    2021-03-30 是YAO啊

    学习啦

    0

  4. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478060, encodeId=84f314e806047, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Wed Mar 31 00:16:57 CST 2021, time=2021-03-31, status=1, ipAttribution=)]
    2021-04-01 ms2000000117745431

    学习

    0

  5. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478060, encodeId=84f314e806047, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Wed Mar 31 00:16:57 CST 2021, time=2021-03-31, status=1, ipAttribution=)]
    2021-03-31 gongliu

    #滤泡性淋巴瘤#

    0

  6. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478060, encodeId=84f314e806047, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Wed Mar 31 00:16:57 CST 2021, time=2021-03-31, status=1, ipAttribution=)]
    2021-03-31 changjitao2009

    #Car-T细胞疗法#

    0

  7. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478060, encodeId=84f314e806047, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Wed Mar 31 00:16:57 CST 2021, time=2021-03-31, status=1, ipAttribution=)]
    2021-03-31 chentianping

    #日本#

    0

  8. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478060, encodeId=84f314e806047, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Wed Mar 31 00:16:57 CST 2021, time=2021-03-31, status=1, ipAttribution=)]
    2021-03-31 cathymary

    #DLBCL#

    0

  9. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1478060, encodeId=84f314e806047, content=<a href='/topic/show?id=bb6f18030a4' target=_blank style='color:#2F92EE;'>#T细胞疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18030, encryptionId=bb6f18030a4, topicName=T细胞疗法)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bea7392214, createdName=124984edm24暂无昵称, createdTime=Wed Mar 31 00:16:57 CST 2021, time=2021-03-31, status=1, ipAttribution=)]
    2021-03-31 839640778

    #日本厚生劳动省#

    0

  10. 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    2021-03-31 124984edm24暂无昵称

    #T细胞疗法#

    0

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Blood：阿托珠单抗用于初治的aaIPI≥1的DLBCL患者的疗效不优于利妥昔单抗

利妥昔单抗联合多种化疗是弥漫性大B细胞淋巴瘤的标准治疗方案。阿托珠单抗是一种单克隆抗体，靶向前体B细胞和成熟B淋巴细胞表面的CD20抗原。该试验旨在对比阿托珠单抗和利妥昔单抗用于DLBCL的疗效

Blood：肿瘤靶向纳米颗粒可改善BCL2和MCL1双重抑制的治疗效果

双重抑制MCL1和BCL2蛋白可使DLBCL小鼠模型获得持久的缓解。包裹在肿瘤靶向纳米颗粒中的S63845或维奈托克可改善双重抑制MCL1和BCL2蛋白的治疗指数。

J Clin Oncol：简化版老年患者评估量表在DLBCL老年患者中的应用

本研究是一项前瞻性的DLBCL老年患者项目研究，旨在前瞻性地验证简化的老年评估（sGA）在诊断中的应用

Blood：根据基因表达亚群将DLBCL分成新的亚型

弥漫性大B细胞淋巴瘤是一种异质性疾病，一般根据细胞来源(COO)的分子亚型进行描述。研究人员尝试通过对新诊断的新发DLBCL患者基因表达谱的大型公共数据集的无监督分析来识别新的患者亚群，并且得到了两个生物学截然不同的亚群，其特征是肿瘤微环境的差异。通路分析和免疫反褶计算法在A亚群中发现了较高的B细胞含量和较强的增殖信号，在B亚群中发现了T细胞、巨噬细胞和免疫/炎症信号的富集，与已发表的DLBCL分

拓展阅读

Haematologica：760例不同亚型LBCL接受CAR-T治疗的结局

近日发表文章，根据组织学亚型报告了英国大型国家数据库中760例接受CD19 CAR-T治疗患者的结局。

CAR-T治疗高端B细胞患者有批次

两项文章研究了CAR-T在高龄大B细胞肿瘤中的应用，一篇在高龄患者亚组中对比CAR-T与免疫化疗，一篇是CAR-T治疗<70岁和≥70岁患者。

​【Cancer Treat Rev】DLBCL中改良R-CHOP的路线图

《Cancer Treatment Reviews》近日发表一篇综述，强调DLBCL治疗面临的挑战，以及开发不再依赖于化疗基石的方案的必要性。

【EHO】R/R DLBCL患者CAR-T治疗失败后异基因移植的结局

近日发表一项苏州大学附属第一医院的单中心回顾性分析，纳入CAR-T治疗后复发并接受allo-HSCT的10例R/R DLBCL患者的结局。

【Cancer Lett】CD30在EBV+DLBCL中高表达的调控机制及其影响预后的分子机制

江苏省人民医院学者开展一项研究，旨在全面系统地探索CD30在EBV+DLBCL中高表达的调控机制及其影响预后的分子机制，近期发表于《Cancer Letters》，通讯作者为徐卫教授和梁金花教授。

【Semin Hematol】弥漫性大B细胞淋巴瘤的流行病学和病原学

《Seminars in Hematology》近日发表一篇文章，阐述了弥漫性大B细胞淋巴瘤的流行病学和病原学。