FDA批准Kyowa Kirin的CCR4单抗Poteligeo 治疗皮肤淋巴瘤

2018-08-09 MedSci MedSci原创

Kyowa Kirin公司的Poteligeo(mogamulizumab-kpkc)已被FDA批准用于曾经接受过全身治疗后复发或难治性蕈样真菌病(MF)或塞泽里综合征(SS)的成年患者。Poteligeo是目前第一种注册用于治疗SS的药物。

Kyowa Kirin公司的Poteligeo(mogamulizumab-kpkc)已被FDA批准用于曾经接受过全身治疗后复发或难治性蕈样真菌病(MF)或塞泽里综合征(SS)的成年患者。Poteligeo是目前第一种注册用于治疗SS的药物。

MF和SS都是罕见的并且很难治疗的非霍奇金淋巴瘤(NHL),统称为皮肤T细胞淋巴瘤(CTCL)。MF占所有病例的大约一半,该疾病通常生长缓慢经过药物控制多年后,仍然会扩散到身体的其他部位。SS同时影响皮肤和淋巴结,有些人认为它可能是MF的后期阶段。这两种癌症的主要问题之一是延迟诊断,因为其症状包括红色、鳞状皮肤和瘙痒,都可能被误认为是其他皮肤病。

根据美国食品和药物管理局的说法,目前的治疗方案包括类固醇、化学疗法、放射疗法和紫外线治疗,但是对于没有应答的患者需要额外的治疗选择。局部治疗用于较轻微的病例,其次是全身治疗,Poteligeo现在提供额外的选择。

Poteligeo通过靶向趋化因子受体CCR4,阻断其与配体(TARC和MDC)结合,从而抑制调节性T细胞在肿瘤部位的募集,介导对肿瘤细胞的杀伤。

Kyowa Kirin在III期MAVORIC研究中测试了Poteligeo的药效,该研究包括372名MF和SS患者,他们每周注射Poteligeo或用默沙东的HDAC抑制剂Zolinza(伏立诺他)作为每日口服剂量给予化疗。Kyowa Kirin抗体的无进展生存期为7.6个月,Zolinza的无进展生存期为3.1个月,MF和SS患者以及癌症的不同阶段都有所改善。

去年,FDA批准了Poteligeo的优先审查和突破状态,并且还向EMA提交了一份申请,以支持欧洲市场营销。该公司表示计划在第四季度在美国推出该产品。

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    2018-08-16 1e145228m78(暂无匿称)

    学习了,谢谢作者分享!

    0

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    2018-08-11 zhenjiu124
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    2018-08-11 kafei

    学习了谢谢

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1941468, encodeId=d53a194146869, content=<a href='/topic/show?id=cc371453291' target=_blank style='color:#2F92EE;'>#Poteligeo#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14532, encryptionId=cc371453291, topicName=Poteligeo)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4fd6156, createdName=oliver169, createdTime=Wed Nov 14 20:52:00 CST 2018, time=2018-11-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839611, encodeId=baba18396110f, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Apr 11 16:52:00 CST 2019, time=2019-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=338968, encodeId=9b5233896873, content=学习了,谢谢作者分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3xJXLtMtt5B40XXuPjn9xn1rBhrM6fHLkX1hI86ZoWoPJkgDkZuJNKkBfBHOcRd1fAdezg7JlHNOokohdAp3WkI/0, createdBy=32c81964262, createdName=1e145228m78(暂无匿称), createdTime=Thu Aug 16 12:01:20 CST 2018, time=2018-08-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1426359, encodeId=26ec142635978, content=<a href='/topic/show?id=032b948ec5' target=_blank style='color:#2F92EE;'>#IgE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9487, encryptionId=032b948ec5, topicName=IgE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0cff4064659, createdName=zhenjiu124, createdTime=Sat Aug 11 13:52:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337801, encodeId=962633e801bc, content=学习了谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLbTp9nZtjwVrSZNxAXbAicnKQWnic2eBdJUQYhxO36XdkstSicr7FVF8p5ReH4omtmsbnLdvZLiaJJ1A/132, createdBy=8bff2327056, createdName=kafei, createdTime=Sat Aug 11 00:38:47 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337592, encodeId=aa9f33e592f0, content=学习了,谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Thu Aug 09 23:34:15 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337587, encodeId=a1fd33e587dd, content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Thu Aug 09 23:07:49 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337582, encodeId=21fa33e5825e, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Aug 09 23:05:47 CST 2018, time=2018-08-09, status=1, ipAttribution=)]
    2018-08-09 惠映实验室

    学习了,谢谢分享。

    0

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    2018-08-09 orangesking

    看看

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1941468, encodeId=d53a194146869, content=<a href='/topic/show?id=cc371453291' target=_blank style='color:#2F92EE;'>#Poteligeo#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14532, encryptionId=cc371453291, topicName=Poteligeo)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4fd6156, createdName=oliver169, createdTime=Wed Nov 14 20:52:00 CST 2018, time=2018-11-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839611, encodeId=baba18396110f, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Apr 11 16:52:00 CST 2019, time=2019-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=338968, encodeId=9b5233896873, content=学习了,谢谢作者分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3xJXLtMtt5B40XXuPjn9xn1rBhrM6fHLkX1hI86ZoWoPJkgDkZuJNKkBfBHOcRd1fAdezg7JlHNOokohdAp3WkI/0, createdBy=32c81964262, createdName=1e145228m78(暂无匿称), createdTime=Thu Aug 16 12:01:20 CST 2018, time=2018-08-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1426359, encodeId=26ec142635978, content=<a href='/topic/show?id=032b948ec5' target=_blank style='color:#2F92EE;'>#IgE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9487, encryptionId=032b948ec5, topicName=IgE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0cff4064659, createdName=zhenjiu124, createdTime=Sat Aug 11 13:52:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337801, encodeId=962633e801bc, content=学习了谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLbTp9nZtjwVrSZNxAXbAicnKQWnic2eBdJUQYhxO36XdkstSicr7FVF8p5ReH4omtmsbnLdvZLiaJJ1A/132, createdBy=8bff2327056, createdName=kafei, createdTime=Sat Aug 11 00:38:47 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337592, encodeId=aa9f33e592f0, content=学习了,谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Thu Aug 09 23:34:15 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337587, encodeId=a1fd33e587dd, content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Thu Aug 09 23:07:49 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337582, encodeId=21fa33e5825e, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Aug 09 23:05:47 CST 2018, time=2018-08-09, status=1, ipAttribution=)]
    2018-08-09 清风拂面

    谢谢分享学习

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