Baidu
map

Shire胰腺癌新药Onivyde获欧盟委员会批准

2016-10-24 佚名 生物谷

  近日,Shire肿瘤管线在欧洲监管方面收获好消息,EMA批准Shire的Onivyde用于治疗胰腺癌,这是继今年七月份该药物获得FDA批准后,再次获得的上市许可。此次EMA批准Onivyde与5-FU和甲酰四氢叶酸联用,用于既往接受过吉西他滨治疗的转移性胰腺癌患者。 这次获批主要是基于一项名为NAPOLI-1的关键III期临床试验数据。数据显示Onivyde和5-FU/L

近日,Shire肿瘤管线在欧洲监管方面收获好消息,EMA批准Shire的Onivyde用于治疗胰腺癌,这是继今年七月份该药物获得FDA批准后,再次获得的上市许可。此次EMA批准Onivyde与5-FU和甲酰四氢叶酸联用,用于既往接受过吉西他滨治疗的转移性胰腺癌患者。

这次获批主要是基于一项名为NAPOLI-1的关键III期临床试验数据。数据显示Onivyde和5-FU/LV联用后,患者的中位总体生存期达到6.1个月,而对照组5-FU/LV的中位总体生存期为4.2个月,显著地延长了患者的生存时间,达到了该临床研究的主要终点。此外,Onivyde/5-FU/LV治疗显著延长患者的无进展生存期(PFS),客观缓解率也高于对照组。安全性方面,最常见的3级及以上不良事件为中性粒细胞减少、疲倦、腹泻和呕吐,试验组发生率高于对照组5个百分点。

Shire全球研发负责人Philip Vickers表示,Onivyde是目前唯一一个显著延长既往接受过吉西他滨治疗的转移性胰腺癌患者生存期的药物,希望这一创新药物能够为患者带来新的希望。

胰腺癌是欧洲致死率排名第三的恶性肿瘤,去年的ESMO年会上,Shire表示该药物有望在全球范围内成为继一线治疗——吉西他滨之后治疗胰腺癌最佳的二线用药。

Onivyde最初是由Onivyde研发的,今年年初被Shire收购。目前全球胰腺癌药物市场正急剧扩张,在Celgene的Abraxane (nab-paclitaxel)的强劲推动下,有望在2017年之前,从2012年的5.29亿美元飙升到16亿美元。

原始出处



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 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1675161, encodeId=55d116e516156, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Wed Mar 29 02:00:00 CST 2017, time=2017-03-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2036813, encodeId=c5c02036813af, content=<a href='/topic/show?id=54f81338108' target=_blank style='color:#2F92EE;'>#Onivyde#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13381, encryptionId=54f81338108, topicName=Onivyde)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2f8f432, createdName=longerg, createdTime=Thu Apr 06 14:00:00 CST 2017, time=2017-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2007863, encodeId=1dc6200e86322, content=<a href='/topic/show?id=601512826f6' target=_blank style='color:#2F92EE;'>#NIV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Fri Jun 02 09:00:00 CST 2017, time=2017-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627678, encodeId=fe6e162e67888, content=<a href='/topic/show?id=6e8c63116d3' target=_blank style='color:#2F92EE;'>#欧盟委员会#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63116, encryptionId=6e8c63116d3, topicName=欧盟委员会)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4df621126020, createdName=wangtianj2014@, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=)]
    2017-03-29 liuli5088
  2. [GetPortalCommentsPageByObjectIdResponse(id=1675161, encodeId=55d116e516156, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Wed Mar 29 02:00:00 CST 2017, time=2017-03-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2036813, encodeId=c5c02036813af, content=<a href='/topic/show?id=54f81338108' target=_blank style='color:#2F92EE;'>#Onivyde#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13381, encryptionId=54f81338108, topicName=Onivyde)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2f8f432, createdName=longerg, createdTime=Thu Apr 06 14:00:00 CST 2017, time=2017-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2007863, encodeId=1dc6200e86322, content=<a href='/topic/show?id=601512826f6' target=_blank style='color:#2F92EE;'>#NIV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Fri Jun 02 09:00:00 CST 2017, time=2017-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627678, encodeId=fe6e162e67888, content=<a href='/topic/show?id=6e8c63116d3' target=_blank style='color:#2F92EE;'>#欧盟委员会#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63116, encryptionId=6e8c63116d3, topicName=欧盟委员会)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4df621126020, createdName=wangtianj2014@, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=)]
    2017-04-06 longerg
  3. [GetPortalCommentsPageByObjectIdResponse(id=1675161, encodeId=55d116e516156, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Wed Mar 29 02:00:00 CST 2017, time=2017-03-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2036813, encodeId=c5c02036813af, content=<a href='/topic/show?id=54f81338108' target=_blank style='color:#2F92EE;'>#Onivyde#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13381, encryptionId=54f81338108, topicName=Onivyde)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2f8f432, createdName=longerg, createdTime=Thu Apr 06 14:00:00 CST 2017, time=2017-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2007863, encodeId=1dc6200e86322, content=<a href='/topic/show?id=601512826f6' target=_blank style='color:#2F92EE;'>#NIV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Fri Jun 02 09:00:00 CST 2017, time=2017-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627678, encodeId=fe6e162e67888, content=<a href='/topic/show?id=6e8c63116d3' target=_blank style='color:#2F92EE;'>#欧盟委员会#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63116, encryptionId=6e8c63116d3, topicName=欧盟委员会)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4df621126020, createdName=wangtianj2014@, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=)]
    2017-06-02 tamgche
  4. [GetPortalCommentsPageByObjectIdResponse(id=1675161, encodeId=55d116e516156, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Wed Mar 29 02:00:00 CST 2017, time=2017-03-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2036813, encodeId=c5c02036813af, content=<a href='/topic/show?id=54f81338108' target=_blank style='color:#2F92EE;'>#Onivyde#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13381, encryptionId=54f81338108, topicName=Onivyde)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2f8f432, createdName=longerg, createdTime=Thu Apr 06 14:00:00 CST 2017, time=2017-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2007863, encodeId=1dc6200e86322, content=<a href='/topic/show?id=601512826f6' target=_blank style='color:#2F92EE;'>#NIV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Fri Jun 02 09:00:00 CST 2017, time=2017-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627678, encodeId=fe6e162e67888, content=<a href='/topic/show?id=6e8c63116d3' target=_blank style='color:#2F92EE;'>#欧盟委员会#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63116, encryptionId=6e8c63116d3, topicName=欧盟委员会)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4df621126020, createdName=wangtianj2014@, createdTime=Wed Oct 26 11:00:00 CST 2016, time=2016-10-26, status=1, ipAttribution=)]

相关资讯

Shire将再次提交小儿多动症药物SHP 465美国上市申请

英国制药公司Shire的多动症药物SHP465近日将迎来美国监管方面的又一个重大转机,据悉,Shire已经完成对该药物的安全性和有效性方面的临床试验,计划在今年年底之前重新向FDA提交上市申请。 SHP465与Shire已上市的ADHD药物Adderall XR(安非他明缓释胶囊)具有相同的活性药物成分(苯丙胺盐混合物)。SHP465是一种长效药物,药效持续长达16个小时,对于ADHD成人患者来

Shire在美国推出干眼病新药Xiidra,艾尔健丽眼达(Restasis)霸主地位不保

英国制药公司Shire近日宣布,在美国市场推出眼科药物Xiidra(lifitegrast滴眼液),该药于今年7月11日获得美国食品和药物管理局(FDA)批准,用于干眼病(DED)症状和体征的治疗,这是FDA批准的首个治疗干眼病的淋巴细胞功能相关抗原 1(LFA-1) 拮抗剂类新药,同时也是美国市场中唯一一种处方滴眼液,每日使用2次,每次相隔大约12小时。 Xiidra是过去13年里干眼病治疗领

FDA批准NPS罕见病药物Natpara,Shire收购初现收获

在经过长时间的权衡后,美国FDA最近正式宣布批准NPS公司开发的罕见病药物Natpara上市。这种注射用药物主要是通过替代人体的甲状旁腺激素来治疗一种名为甲状旁腺功能减退的罕见内分泌紊乱疾病。这种疾病会导致患者钙缺乏和维生素D合成受阻,并最终导致包括肌肉疼痛、骨密度问题等并发症。在一些急性病例中甚至会导致心律失常的后果。 Natpara的申报之路可谓是一波多折。先是FDA将其先行实验数据审查的时

盘点:2015年全球生物制药行业前十五大并购

图片来自Yuri Arcurs/Fotolia.com 当谈论并购(mergers and acquisitions, M&A)时,数字通常能说明问题。 2015年最大的交易,辉瑞公司(Pfizer)计划出资1600亿美元收购艾尔建公司(Allergan),是制药公司之间有史以来最大的并购,也是2014年第一大M&A交易数额---阿特维斯公司(Activis)支付7

Baidu
map
Baidu
map
Baidu
map