FDA批准Seattle Genetics的Adcetris治疗外周T细胞淋巴瘤

2018-11-18 MedSci MedSci原创

Seattle Genetics公司近日宣布,其Adcetris(brentuximab vedotin)与化学疗法相结合的方案,获得了美国的批准,以治疗患有先前未治疗的全身性间变性大细胞淋巴瘤(sALCL)或其他表达CD30的外周T细胞淋巴瘤(PTCL)的成人患者。

Seattle Genetics公司近日宣布,其Adcetrisbrentuximab vedotin)与化学疗法相结合的方案,获得了美国的批准,以治疗患有先前未治疗的全身性间变性大细胞淋巴瘤sALCL)或其他表达CD30的外周T细胞淋巴瘤PTCL)的成人患者。该公司指出,在向FDA的实时肿瘤学评估试点计划提交申请后的两周内,其申请即获得了批准。

FDA血液学和肿瘤学产品办公室代理主任Richard Pazdur说:实时肿瘤学评估计划允许FDA在制药公司正式提交申请之前访问关键数据,允许审核小组提前开始审核并在申请实际提交前与制药公司进行沟通。这项批准得到了第三阶段ECHELON-2试验数据的支持,该研究比较了Adcetris联合CHP化疗(由环磷酰胺、多柔比星和泼尼松组成)方案与CHOP化疗(由环磷酰胺、阿霉素、长春新碱和泼尼松组成)方案的差异。据Seattle Genetics报道,ECHELON-2证明,Adcetris联合CHP方案在无进展生存期(PFS)方面优于CHOP方案,Adcetris联合CHP方案可降低疾病进展的风险。


原始出处:

http://www.firstwordpharma.com/node/1605118#axzz5XAXlsKfr

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    2018-12-12 cy0324
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    2019-09-16 huperzia
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createdName=江川靖瑶, createdTime=Tue May 07 04:09:00 CST 2019, time=2019-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1878004, encodeId=ef0418e8004aa, content=<a href='/topic/show?id=5d80e943ef' target=_blank style='color:#2F92EE;'>#Genetics#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7943, encryptionId=5d80e943ef, topicName=Genetics)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca89104, createdName=huperzia, createdTime=Mon Sep 16 09:09:00 CST 2019, time=2019-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1734083, encodeId=8b6e1e34083ce, content=<a href='/topic/show?id=d4f412668a4' target=_blank style='color:#2F92EE;'>#NET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12668, encryptionId=d4f412668a4, topicName=NET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ea033781210, createdName=canlab, createdTime=Wed Aug 21 00:09:00 CST 2019, time=2019-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1702529, encodeId=cfff1e02529fc, content=<a href='/topic/show?id=ddc9e795159' target=_blank style='color:#2F92EE;'>#细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77951, encryptionId=ddc9e795159, topicName=细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=201630414353, createdName=marlenexl, createdTime=Sat Mar 16 17:09:00 CST 2019, time=2019-03-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1954081, encodeId=ba8c1954081a2, content=<a href='/topic/show?id=163116089c7' target=_blank style='color:#2F92EE;'>#Seattle#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16089, encryptionId=163116089c7, topicName=Seattle)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Tue Sep 17 04:09:00 CST 2019, time=2019-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839636, encodeId=85231839636d1, 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=30, 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=Wed Jan 16 00:09:00 CST 2019, time=2019-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1947275, encodeId=7a63194e275fc, content=<a href='/topic/show?id=94841958f6' target=_blank style='color:#2F92EE;'>#Adcetris#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1958, encryptionId=94841958f6, topicName=Adcetris)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIOca9icPByKxo3ZRUrvuibf7tWt7EScQ1NEiaKy4NCUctSU2jDjOayLicDIaicwUxaQhJ1SZKdEevgjRg/132, createdBy=4f272500131, createdName=若水123, createdTime=Sun Dec 09 04:09:00 CST 2018, time=2018-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1312212, encodeId=7f121312212ff, content=<a href='/topic/show?id=029d42e9060' target=_blank style='color:#2F92EE;'>#外周T细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42790, encryptionId=029d42e9060, topicName=外周T细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=570f404, createdName=xlxchina, createdTime=Tue Nov 20 03:09:00 CST 2018, time=2018-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372647, encodeId=ce0813e2647f7, content=<a href='/topic/show?id=7d2d1802820' target=_blank style='color:#2F92EE;'>#T细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18028, encryptionId=7d2d1802820, topicName=T细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bfa6343, createdName=aliceclz, createdTime=Tue Nov 20 03:09:00 CST 2018, time=2018-11-20, status=1, ipAttribution=)]
    2019-08-21 canlab
  5. [GetPortalCommentsPageByObjectIdResponse(id=2049109, encodeId=d9ec20491093b, content=<a href='/topic/show?id=4363e929ad' target=_blank style='color:#2F92EE;'>#Gene#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7929, encryptionId=4363e929ad, topicName=Gene)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=63a4277, createdName=cy0324, createdTime=Wed Dec 12 07:09:00 CST 2018, time=2018-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1686260, encodeId=a967168626043, content=<a href='/topic/show?id=66f3e93862' target=_blank style='color:#2F92EE;'>#Genet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7938, encryptionId=66f3e93862, topicName=Genet)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d3e128296421, createdName=江川靖瑶, createdTime=Tue May 07 04:09:00 CST 2019, time=2019-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1878004, encodeId=ef0418e8004aa, content=<a href='/topic/show?id=5d80e943ef' target=_blank style='color:#2F92EE;'>#Genetics#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7943, encryptionId=5d80e943ef, topicName=Genetics)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca89104, createdName=huperzia, createdTime=Mon Sep 16 09:09:00 CST 2019, time=2019-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1734083, encodeId=8b6e1e34083ce, content=<a href='/topic/show?id=d4f412668a4' target=_blank style='color:#2F92EE;'>#NET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12668, 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authenticateStatus=null, createdAvatar=, createdBy=570f404, createdName=xlxchina, createdTime=Tue Nov 20 03:09:00 CST 2018, time=2018-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372647, encodeId=ce0813e2647f7, content=<a href='/topic/show?id=7d2d1802820' target=_blank style='color:#2F92EE;'>#T细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18028, encryptionId=7d2d1802820, topicName=T细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bfa6343, createdName=aliceclz, createdTime=Tue Nov 20 03:09:00 CST 2018, time=2018-11-20, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=2049109, encodeId=d9ec20491093b, content=<a href='/topic/show?id=4363e929ad' target=_blank style='color:#2F92EE;'>#Gene#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7929, encryptionId=4363e929ad, topicName=Gene)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=63a4277, createdName=cy0324, createdTime=Wed Dec 12 07:09:00 CST 2018, time=2018-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1686260, encodeId=a967168626043, content=<a href='/topic/show?id=66f3e93862' target=_blank style='color:#2F92EE;'>#Genet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7938, encryptionId=66f3e93862, topicName=Genet)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d3e128296421, 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authenticateStatus=null, createdAvatar=, createdBy=570f404, createdName=xlxchina, createdTime=Tue Nov 20 03:09:00 CST 2018, time=2018-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1372647, encodeId=ce0813e2647f7, content=<a href='/topic/show?id=7d2d1802820' target=_blank style='color:#2F92EE;'>#T细胞淋巴瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18028, encryptionId=7d2d1802820, topicName=T细胞淋巴瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bfa6343, createdName=aliceclz, createdTime=Tue Nov 20 03:09:00 CST 2018, time=2018-11-20, status=1, ipAttribution=)]
    2019-09-17 仁医06
  7. 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