Mallinckrodt的UVADEX(甲氧沙林)获得澳大利亚批准,与THERAKOS CELLEX光电穿刺系统联合治疗成人慢性移植物抗宿主疾病和T细胞淋巴瘤

2019-11-04 不详 MedSci原创

Mallinckrodt公司宣布,UVADEX(甲氧沙林)获得澳大利亚管理局(TGA)批准,与THERAKOS CELLEX光电穿刺系统联合,用于同种异体造血干细胞(HSC)移植后类固醇难治和类固醇不耐受的慢性移植物抗宿主病(cGvHD)。TGA还批准了Uvadex与THERAKOS CELLEX 光电穿刺系统联合用于姑息治疗对其他治疗无反应的皮肤T细胞淋巴瘤(CTCL)的皮肤症状。

Mallinckrodt公司宣布,UVADEX(甲氧沙林)获得澳大利亚管理局(TGA)批准,与THERAKOS CELLEX光电穿刺系统联合,用于同种异体造血干细胞(HSC)移植后类固醇难治和类固醇不耐受的慢性移植物抗宿主病(cGvHD)。TGA还批准了Uvadex与THERAKOS CELLEX 光电穿刺系统联合用于姑息治疗对其他治疗无反应的皮肤T细胞淋巴瘤(CTCL)的皮肤症状。

TGA批准UVADEX与THERAKOS光电穿刺系统联合用于成人慢性移植物抗宿主疾病的治疗,标志着世界上第一个联合使用的适应症标签和监管机构的批准。

Mallinckrodt执行副总裁兼首席科学官医学博士Steven Romano表示:"通过Therakos ECP平台获得UVADEX的TGA批准,为具有这些挑战性疾病的患者提供了新的治疗选择。cGvHD适应症也是Mallinckrodt的重要里程碑,证实了这种治疗方案对难治性或不耐受类固醇治疗的患者的潜在益处。"

移植物抗宿主病是造血干细胞(HSC)移植的常见并发症,可导致明显的发病率和死亡率。根据临床表现和移植后发生的时间可分为急性或慢性。cGvHD的体征和症状几乎总是在移植后的第一年内发生,但偶尔会在几年后发生。在cGvHD中,皮肤是受影响最频繁的器官,表现为瘙痒性皮疹、色素沉着过度或色素不足以及质地改变。但是,该疾病可以影响多个部位,可对患者的生活质量产生重大影响。慢性GvHD可能导致关节挛缩、视力丧失、末期肺部疾病,或由于慢性免疫抑制导致反复发作或危及生命的感染而导致的死亡。

皮肤T细胞淋巴瘤(CTCL)是一组涉及皮肤T淋巴细胞的非霍奇金淋巴瘤的总称。它是一种相对罕见的癌症,在美国每年有2500至3000个新病例。该病的发病年龄通常大于50岁,在生命的后几十年中发病率显着上升。CTCL会导致可见的皮肤症状,从小疹子到全身泛红,脱皮,灼热,酸痛和瘙痒。

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encodeId=dd121e453311b, content=<a href='/topic/show?id=bdc262694bb' target=_blank style='color:#2F92EE;'>#植物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62694, encryptionId=bdc262694bb, topicName=植物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6a5e35527958, createdName=xuyong535, createdTime=Sat Feb 15 05:53:00 CST 2020, time=2020-02-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=374892, encodeId=ec493e489236, content=学习到了,打卡, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4e612177064, createdName=dandande1994_64316415, createdTime=Thu Nov 07 08:51:45 CST 2019, time=2019-11-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1620742, encodeId=d6f61620e42e3, content=<a href='/topic/show?id=c0c9e520310' target=_blank style='color:#2F92EE;'>#移植物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75203, encryptionId=c0c9e520310, topicName=移植物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=153620156575, createdName=10518100zz, createdTime=Wed Nov 06 01:53:00 CST 2019, time=2019-11-06, status=1, ipAttribution=)]
    2020-03-21 zll0625
  5. 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  6. 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encodeId=d6f61620e42e3, content=<a href='/topic/show?id=c0c9e520310' target=_blank style='color:#2F92EE;'>#移植物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75203, encryptionId=c0c9e520310, topicName=移植物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=153620156575, createdName=10518100zz, createdTime=Wed Nov 06 01:53:00 CST 2019, time=2019-11-06, status=1, ipAttribution=)]
    2020-04-18 维他命
  7. 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  8. 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encodeId=d6f61620e42e3, content=<a href='/topic/show?id=c0c9e520310' target=_blank style='color:#2F92EE;'>#移植物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75203, encryptionId=c0c9e520310, topicName=移植物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=153620156575, createdName=10518100zz, createdTime=Wed Nov 06 01:53:00 CST 2019, time=2019-11-06, status=1, ipAttribution=)]
    2020-02-15 xuyong535
  9. 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    2019-11-07 dandande1994_64316415

    学习到了,打卡

    0

  10. 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