FDA批准Monjuvi(tafasitamab-cxix)联合来那度胺治疗复发难治弥漫性大B细胞淋巴瘤

2020-08-03 Allan MedSci原创

美国食品药品监督管理局(FDA)已批准Monjuvi(tafasitamab-cxix)联合来那度胺治疗复发或难治性弥漫性大B细胞淋巴瘤(DLBCL)且不适合自体干细胞移植(ASCT)的成人患者。

制药公司MorphoSys和Incyte今日宣布,美国食品药品监督管理局(FDA)已批准Monjuvi®(tafasitamab-cxix)联合来那度胺治疗复发或难治性弥漫性大B细胞淋巴瘤(DLBCL)且不适合自体干细胞移植(ASCT)的成人患者。Tafasitamab-cxix是人源化靶向CD19的单克隆抗体,已获得美国FDA的加速批准。

DLBCL是全世界成年人中最常见的非霍奇金淋巴瘤,其特征是淋巴结、脾脏、肝脏、骨髓或其他器官中恶性B细胞的数量的迅速增长。DLBCL是一种侵略性疾病,大约三分之一的患者对初始治疗无效。在美国,每年约有10,000名被诊断患有复发性或难治性DLBCL。根据其基因活性,DLBL可分为3种主要亚型:活化B细胞淋巴瘤(ABC-DLBCL)、生发中心B细胞淋巴瘤(GCB-DLBCL)和原发纵隔大B细胞淋巴瘤(PMBL)。

Incyte首席执行官HervéHoppenot表示:“FDA批准Monjuvi与来那度胺合用有助于解决美国复发性或难治性DLBCL患者的紧急医疗需求。在Inccyte,我们致力于提高患者的护理水平”。

 

原始出处:

https://www.firstwordpharma.com/node/1745580

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    2021-03-02 bugit
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href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=16, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Mon Nov 30 17:08:28 CST 2020, time=2020-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806530, encodeId=8c3e806530ff, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200803/d669a8255ef042b4b50cb4b323fac1e4/3da0f519fc71432ca9a2f4c05279c082.jpg, createdBy=a8312408082, createdName=chenny, createdTime=Thu Aug 06 14:18:13 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273365, encodeId=7a3d12e336511, content=<a href='/topic/show?id=310d383ef5' target=_blank style='color:#2F92EE;'>#B细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3837, encryptionId=310d383ef5, topicName=B细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eba113, createdName=xiaoyeshuang, createdTime=Wed Aug 05 02:08:28 CST 2020, time=2020-08-05, status=1, ipAttribution=)]
    2021-04-05 gaoxiaoe
  5. 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GetPortalCommentsPageByObjectIdResponse(id=1273365, encodeId=7a3d12e336511, content=<a href='/topic/show?id=310d383ef5' target=_blank style='color:#2F92EE;'>#B细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3837, encryptionId=310d383ef5, topicName=B细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eba113, createdName=xiaoyeshuang, createdTime=Wed Aug 05 02:08:28 CST 2020, time=2020-08-05, status=1, ipAttribution=)]
    2021-07-09 zhanglin3079
  6. 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href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=16, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Mon Nov 30 17:08:28 CST 2020, time=2020-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806530, encodeId=8c3e806530ff, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200803/d669a8255ef042b4b50cb4b323fac1e4/3da0f519fc71432ca9a2f4c05279c082.jpg, createdBy=a8312408082, createdName=chenny, createdTime=Thu Aug 06 14:18:13 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273365, encodeId=7a3d12e336511, content=<a href='/topic/show?id=310d383ef5' target=_blank style='color:#2F92EE;'>#B细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3837, encryptionId=310d383ef5, topicName=B细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eba113, createdName=xiaoyeshuang, createdTime=Wed Aug 05 02:08:28 CST 2020, time=2020-08-05, status=1, ipAttribution=)]
    2020-09-23 jacinta

    学习了

    0

  7. 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    2020-12-19 gracezdd
  8. 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    2020-11-30 snf701207
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    2020-08-06 chenny

    学习了

    0

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Blood:达雷木单抗+来那度胺+硼替佐米和地塞米松治疗新确诊的可移植的多发性骨髓瘤的疗效

达雷木单抗联合来那度胺/硼替佐米/地塞米松(D-RVd)可改善多发性骨髓瘤患者的晚期缓解率和MRD阴性,且随着时间的推移效果不断提高。 D-RVd方案不会引发新的安全性问题。

拓展阅读

Blood:CAR T 细胞治疗老年复发/难治性弥漫性大 B 细胞淋巴瘤患者的真实世界证据

该研究旨报告了CAR T细胞治疗老年复发/难治性弥漫性大B细胞淋巴瘤患者的真实世界证据。

Blood:国际SCHOLAR-1研究结果:难治性弥漫性大B细胞淋巴瘤的预后情况。

弥漫性大B细胞淋巴瘤(DLBCL)是非霍奇金淋巴瘤最常见的亚型。虽然一线5年生存率有60%-70%,但高达50%的患者会进展成难治性或治疗后复发。已发表的对难治性DLBCL患者的大规模预后数据分析有限。