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FDA接受了赛诺菲的申请，要求批准isatuximab用于复发难治多发性骨髓瘤患者

2019-07-11 Allan MedSci原创

isatuximab复发难治多发性骨髓瘤CD38
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赛诺菲公司近日宣布，FDA接受了isatuximab治疗复发难治多发性骨髓瘤的申请。预计FDA将于2020年4月30日前就CD38受体抑制剂isatuximab的批准做出最终决定。

赛诺菲公司近日宣布，FDA接受了isatuximab治疗复发难治多发性骨髓瘤的申请。预计FDA将于2020年4月30日前就CD38受体抑制剂isatuximab的批准做出最终决定。

赛诺菲表示，该申请是基于III期ICARIA-MM试验的数据。该研究结果于上个月在美国临床肿瘤学会（ASCO）年会上发表，最近又在欧洲血液学协会（EHA）大会上公布。结果显示，isatuximab与Celgene的Pomalyst（pomalidomide）和地塞米松联合使用，显著延长了复发难治多发性骨髓瘤患者的无进展生存期（PFS）。赛诺菲指出，isatuximab已被FDA和欧洲药品管理局（EMA）授予孤儿药认定用于治疗复发难治性多发性骨髓瘤。


原始出处：

http://www.firstwordpharma.com/node/1652198#axzz5tMRLVCBr

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    2020-05-23 jml2009

    #多发性#

    0

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    2020-06-19 snf701207

    #mAb#

    0

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    2019-09-14 lqvr

    #复发难治多发性骨髓瘤#

    0

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    2020-06-22 luoxiaog

    #复发难治#

    0

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    2019-07-15 1ddf0692m34(暂无匿称)

    学习了，谢谢分享

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1890035, encodeId=699b189003544, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Sat May 23 01:56:00 CST 2020, time=2020-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912173, encodeId=74d019121e3cf, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Fri Jun 19 01:56:00 CST 2020, time=2020-06-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1952538, encodeId=1642195253860, content=<a href='/topic/show?id=59af42591bc' target=_blank style='color:#2F92EE;'>#复发难治多发性骨髓瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42591, encryptionId=59af42591bc, topicName=复发难治多发性骨髓瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Sat Sep 14 18:56:00 CST 2019, time=2019-09-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2046430, encodeId=58cc20464307b, content=<a href='/topic/show?id=830c4258913' target=_blank style='color:#2F92EE;'>#复发难治#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42589, encryptionId=830c4258913, topicName=复发难治)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Mon Jun 22 06:56:00 CST 2020, time=2020-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=369716, encodeId=7589369e1637, content=学习了，谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Mon Jul 15 19:06:29 CST 2019, time=2019-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1422626, encodeId=1fae14226262d, content=<a href='/topic/show?id=8e0d10065ff' target=_blank style='color:#2F92EE;'>#isatuximab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10065, encryptionId=8e0d10065ff, topicName=isatuximab)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e5fc3724043, createdName=qingrejiedu, createdTime=Sat Jul 13 08:56:00 CST 2019, time=2019-07-13, status=1, ipAttribution=)]
    2019-07-13 qingrejiedu

    #isatuximab#

    0