Baidu
map

FDA专家组支持硫酸长春新碱脂质体注射液用于成人ALL治疗

2012-04-10 田磊磊 环球医学

       美国FDA咨询委员会已勉强通过了硫酸长春新碱脂质体注射液(Marqibo)用于治疗一种罕见的成人急性淋巴细胞白血病。        FDA肿瘤药物咨询委员会以7:4的表决结果(两名专家弃权)认定,对于病情两次及两次以上复发或是之前至少两种其他抗白血病药治疗失败且费城染色体为阴性(Ph-)的急性淋

       美国FDA咨询委员会已勉强通过了硫酸长春新碱脂质体注射液(Marqibo)用于治疗一种罕见的成人急性淋巴细胞白血病。

       FDA肿瘤药物咨询委员会以7:4的表决结果(两名专家弃权)认定,对于病情两次及两次以上复发或是之前至少两种其他抗白血病药治疗失败且费城染色体为阴性(Ph-)的急性淋巴细胞白血病(ALL)患者而言,应用硫酸长春新碱脂质体注射液治疗所获益处大于风险。目前尚无FDA批准于这一特殊患者群体治疗的药物。
  硫酸长春新碱脂质体注射液 成人ALL 治疗 FDA
         成人ALL是最罕见的癌症之一,在美国每年约有2000例患者被新确诊为成人ALL(ALL多见于儿童)。在这些患者中,1400例为 Ph- ALL。全部复发性Ph- 成人ALL患者的5年生存率只有7%。

       目前,长春新碱用于多药化疗。Talon制药试图获得将硫酸长春新碱脂质体注射液(简称为VSLI)作为单一疗法注射剂的批准。而通过注射给药,意味着患者不必花时间在医院接受多药化疗。

       周三上午,专家小组审查了Talon制药对65例既往两次或两次以上抗白血病治疗失败的Ph- ALL患者所进行的单组、开放标签、剂量递增II期试验。这项研究的终点是完全缓解率——无论血细胞计数是否完全恢复(被称为CR+CRi)。

       65例患者中有10例(15.4%)达到完全缓解(通过骨髓检查来判断),这些患者的中位缓解期持续28天。

       Talon制药在其简报文件报告了另一个研究结果:接受治疗的整个人群的中位整体生存期为4.6个月,而那些获得CR+CRi者平均存活了7.7个月。一些小组成员似乎看到了希望,接受硫酸长春新碱脂质体注射液治疗而获得CR+CRi的患者的身体状况可以变好,足以接受造血干细胞移植。

       虽然结果数据欠佳,尤其是考虑到在注射最后一剂VSLI之后,仅有5例患者存活超过一年,但Talon制药称,在之前尝试了一两次治疗之后,患者的存活期通常不会超过3个月,而第三或第四次复发的患者的生存期一般只有几周。

       关于该药是否显示出比多药化疗制剂更好的效果尚存争论(虽然该公司并未针对这一问题进行测试)。“是的,我认为这是一个真实的应答率,”投票支持该药的专家小组成员、印第安纳大学梅尔文和布伦西蒙癌症中心的肿瘤科医生、医学博士Patrick Loehrer说。“它提供了一些白血病医生、甚至怀疑者都可以相信的数据。”

       另一位专家小组成员费城儿童医院肿瘤科医生、医学博士Frank Balis并不相信该研究的数据并且投票反对批准该药:“我没有看到把这种已知药物改为新剂型能带来益处。” 

       试验中,接受VSLI治疗患者报告的不良事件包括:便秘、周围神经病变、恶心、感觉减退、感觉异常、中性粒细胞减少、疲劳、贫血、血小板减少和腹痛。

       在治疗期间,超过四分之三的患者报告了严重的不良事件,通常是神经病变。但约80%的患者存在接受早期多药化疗(其中包括长春新碱)治疗时所残留的长春新碱相关性神经病变。

       大部分专家小组成员认为该药的毒性可能比多药化疗药物的毒性小。

       FDA尚未对咨询委员会的建议表态。如果FDA批准硫酸长春新碱脂质体注射液,Talon将需要进行一项III期试验对该药与多药化疗药物进行比较测试,此项试验需要至少348例新确诊的ALL老年患者。  

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1971772, encodeId=b50b19e177211, content=<a href='/topic/show?id=377096965f6' target=_blank style='color:#2F92EE;'>#长春新碱#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96965, encryptionId=377096965f6, topicName=长春新碱)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=644e456, createdName=vera_1203, createdTime=Sat Apr 21 12:37:00 CST 2012, time=2012-04-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1976434, encodeId=ce6319e64347c, content=<a href='/topic/show?id=06fd84425c8' target=_blank style='color:#2F92EE;'>#脂质体#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84425, encryptionId=06fd84425c8, topicName=脂质体)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Wed Jun 06 02:37:00 CST 2012, time=2012-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2029402, encodeId=15d3202940221, content=<a href='/topic/show?id=585a206e45e' target=_blank style='color:#2F92EE;'>#专家组#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20674, encryptionId=585a206e45e, topicName=专家组)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca6a2500099, createdName=more is better!, createdTime=Mon Dec 24 21:37:00 CST 2012, time=2012-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1328827, encodeId=7150132882ee3, content=<a href='/topic/show?id=bb96232801' target=_blank style='color:#2F92EE;'>#ALL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2328, encryptionId=bb96232801, topicName=ALL)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/C2EFD5CFB07FE291138AD4FD0C98E3DE/100, createdBy=e3d52500031, createdName=膀胱癌, createdTime=Thu Apr 12 14:37:00 CST 2012, time=2012-04-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1586501, encodeId=e7cf158650138, content=<a href='/topic/show?id=f87c6499085' target=_blank style='color:#2F92EE;'>#注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64990, encryptionId=f87c6499085, topicName=注射液)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c93417353045, createdName=shijzhiewnjhch, createdTime=Thu Apr 12 14:37:00 CST 2012, time=2012-04-12, status=1, ipAttribution=)]
  2. [GetPortalCommentsPageByObjectIdResponse(id=1971772, encodeId=b50b19e177211, content=<a href='/topic/show?id=377096965f6' target=_blank style='color:#2F92EE;'>#长春新碱#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96965, encryptionId=377096965f6, topicName=长春新碱)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=644e456, createdName=vera_1203, createdTime=Sat Apr 21 12:37:00 CST 2012, time=2012-04-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1976434, encodeId=ce6319e64347c, content=<a href='/topic/show?id=06fd84425c8' target=_blank style='color:#2F92EE;'>#脂质体#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84425, encryptionId=06fd84425c8, topicName=脂质体)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Wed Jun 06 02:37:00 CST 2012, time=2012-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2029402, encodeId=15d3202940221, content=<a href='/topic/show?id=585a206e45e' target=_blank style='color:#2F92EE;'>#专家组#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20674, encryptionId=585a206e45e, topicName=专家组)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca6a2500099, createdName=more is better!, createdTime=Mon Dec 24 21:37:00 CST 2012, time=2012-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1328827, encodeId=7150132882ee3, content=<a href='/topic/show?id=bb96232801' target=_blank style='color:#2F92EE;'>#ALL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2328, encryptionId=bb96232801, topicName=ALL)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/C2EFD5CFB07FE291138AD4FD0C98E3DE/100, createdBy=e3d52500031, createdName=膀胱癌, createdTime=Thu Apr 12 14:37:00 CST 2012, time=2012-04-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1586501, encodeId=e7cf158650138, content=<a href='/topic/show?id=f87c6499085' target=_blank style='color:#2F92EE;'>#注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64990, encryptionId=f87c6499085, topicName=注射液)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c93417353045, createdName=shijzhiewnjhch, createdTime=Thu Apr 12 14:37:00 CST 2012, time=2012-04-12, status=1, ipAttribution=)]
  3. [GetPortalCommentsPageByObjectIdResponse(id=1971772, encodeId=b50b19e177211, content=<a href='/topic/show?id=377096965f6' target=_blank style='color:#2F92EE;'>#长春新碱#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96965, encryptionId=377096965f6, topicName=长春新碱)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=644e456, createdName=vera_1203, createdTime=Sat Apr 21 12:37:00 CST 2012, time=2012-04-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1976434, encodeId=ce6319e64347c, content=<a href='/topic/show?id=06fd84425c8' target=_blank style='color:#2F92EE;'>#脂质体#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84425, encryptionId=06fd84425c8, topicName=脂质体)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Wed Jun 06 02:37:00 CST 2012, time=2012-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2029402, encodeId=15d3202940221, content=<a href='/topic/show?id=585a206e45e' target=_blank style='color:#2F92EE;'>#专家组#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20674, encryptionId=585a206e45e, topicName=专家组)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca6a2500099, createdName=more is better!, createdTime=Mon Dec 24 21:37:00 CST 2012, time=2012-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1328827, encodeId=7150132882ee3, content=<a href='/topic/show?id=bb96232801' target=_blank style='color:#2F92EE;'>#ALL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2328, encryptionId=bb96232801, topicName=ALL)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/C2EFD5CFB07FE291138AD4FD0C98E3DE/100, createdBy=e3d52500031, createdName=膀胱癌, createdTime=Thu Apr 12 14:37:00 CST 2012, time=2012-04-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1586501, encodeId=e7cf158650138, content=<a href='/topic/show?id=f87c6499085' target=_blank style='color:#2F92EE;'>#注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64990, encryptionId=f87c6499085, topicName=注射液)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c93417353045, createdName=shijzhiewnjhch, createdTime=Thu Apr 12 14:37:00 CST 2012, time=2012-04-12, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1971772, encodeId=b50b19e177211, content=<a href='/topic/show?id=377096965f6' target=_blank style='color:#2F92EE;'>#长春新碱#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96965, encryptionId=377096965f6, topicName=长春新碱)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=644e456, createdName=vera_1203, createdTime=Sat Apr 21 12:37:00 CST 2012, time=2012-04-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1976434, encodeId=ce6319e64347c, content=<a href='/topic/show?id=06fd84425c8' target=_blank style='color:#2F92EE;'>#脂质体#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84425, encryptionId=06fd84425c8, topicName=脂质体)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Wed Jun 06 02:37:00 CST 2012, time=2012-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2029402, encodeId=15d3202940221, content=<a href='/topic/show?id=585a206e45e' target=_blank style='color:#2F92EE;'>#专家组#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20674, encryptionId=585a206e45e, topicName=专家组)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca6a2500099, createdName=more is better!, createdTime=Mon Dec 24 21:37:00 CST 2012, time=2012-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1328827, encodeId=7150132882ee3, content=<a href='/topic/show?id=bb96232801' target=_blank style='color:#2F92EE;'>#ALL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2328, encryptionId=bb96232801, topicName=ALL)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/C2EFD5CFB07FE291138AD4FD0C98E3DE/100, createdBy=e3d52500031, createdName=膀胱癌, createdTime=Thu Apr 12 14:37:00 CST 2012, time=2012-04-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1586501, encodeId=e7cf158650138, content=<a href='/topic/show?id=f87c6499085' target=_blank style='color:#2F92EE;'>#注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64990, encryptionId=f87c6499085, topicName=注射液)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c93417353045, createdName=shijzhiewnjhch, createdTime=Thu Apr 12 14:37:00 CST 2012, time=2012-04-12, status=1, ipAttribution=)]
    2012-04-12 膀胱癌
  5. [GetPortalCommentsPageByObjectIdResponse(id=1971772, encodeId=b50b19e177211, content=<a href='/topic/show?id=377096965f6' target=_blank style='color:#2F92EE;'>#长春新碱#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96965, encryptionId=377096965f6, topicName=长春新碱)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=644e456, createdName=vera_1203, createdTime=Sat Apr 21 12:37:00 CST 2012, time=2012-04-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1976434, encodeId=ce6319e64347c, content=<a href='/topic/show?id=06fd84425c8' target=_blank style='color:#2F92EE;'>#脂质体#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84425, encryptionId=06fd84425c8, topicName=脂质体)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Wed Jun 06 02:37:00 CST 2012, time=2012-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2029402, encodeId=15d3202940221, content=<a href='/topic/show?id=585a206e45e' target=_blank style='color:#2F92EE;'>#专家组#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20674, encryptionId=585a206e45e, topicName=专家组)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca6a2500099, createdName=more is better!, createdTime=Mon Dec 24 21:37:00 CST 2012, time=2012-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1328827, encodeId=7150132882ee3, content=<a href='/topic/show?id=bb96232801' target=_blank style='color:#2F92EE;'>#ALL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2328, encryptionId=bb96232801, topicName=ALL)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/C2EFD5CFB07FE291138AD4FD0C98E3DE/100, createdBy=e3d52500031, createdName=膀胱癌, createdTime=Thu Apr 12 14:37:00 CST 2012, time=2012-04-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1586501, encodeId=e7cf158650138, content=<a href='/topic/show?id=f87c6499085' target=_blank style='color:#2F92EE;'>#注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64990, encryptionId=f87c6499085, topicName=注射液)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c93417353045, createdName=shijzhiewnjhch, createdTime=Thu Apr 12 14:37:00 CST 2012, time=2012-04-12, status=1, ipAttribution=)]
Baidu
map
Baidu
map
Baidu
map