FDA接受葛兰素史克的补充新药申请,将其PARP抑制剂Zejula用作对铂类化疗敏感、晚期卵巢癌患者的一线维持治疗

2020-02-25 不详 MedSci原创

葛兰素史克(GlaxoSmithKline)宣布,美国食品药品监督管理局(FDA)接受了该公司提交的补充新药申请(sNDA),以寻求批准其PARP抑制剂Zejula(niraparib)用作晚期卵巢癌女性患者一线治疗的维持治疗药物。这部分患者无论其生物标志物状态如何,均对铂类化疗产生反应。

葛兰素史克(GlaxoSmithKline)宣布,美国食品药品监督管理局(FDA)接受了该公司提交的补充新药申请(sNDA),以寻求批准其PARP抑制剂Zejula(niraparib)用作晚期卵巢癌女性患者一线治疗的维持治疗药物。这部分患者无论其生物标志物状态如何,均对铂类化疗产生反应。

此次申请是基于PRIMA研究(ENGOT-OV26 / GOG-3012)的数据,该数据证明了在一线维持情况下Zejula治疗的临床意义。PRIMA研究的结果在2019年欧洲肿瘤医学学会大会进行了介绍并发表在《新英格兰医学杂志》上。

在美国,卵巢癌每年新诊断的病例达222000名,约85%为晚期卵巢癌且会复发。

Zejula是一种口服的每日一次PARP抑制剂,目前正在多项关键试验中进行评估。

Zejula目前在美国已被批准用作无论BRCA突变状态如何、对铂类化疗敏感的、复发性卵巢癌患者的维持治疗。Zejula也被批准用于经过三种或三种以上的化疗方案后疾病进展的晚期卵巢癌患者的治疗。

原始出处:


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2020, time=2020-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1315777, encodeId=f31f1315e7787, content=<a href='/topic/show?id=6f0188218ee' target=_blank style='color:#2F92EE;'>#葛兰素史克#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88218, encryptionId=6f0188218ee, topicName=葛兰素史克)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Thu Feb 27 09:41:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394568, encodeId=a57e13945683c, content=<a href='/topic/show?id=2c9a5981483' target=_blank style='color:#2F92EE;'>#晚期卵巢癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59814, encryptionId=2c9a5981483, topicName=晚期卵巢癌)], attachment=null, 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    2021-01-14 sunylz
  5. 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2020, time=2020-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1315777, encodeId=f31f1315e7787, content=<a href='/topic/show?id=6f0188218ee' target=_blank style='color:#2F92EE;'>#葛兰素史克#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88218, encryptionId=6f0188218ee, topicName=葛兰素史克)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Thu Feb 27 09:41:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394568, encodeId=a57e13945683c, content=<a href='/topic/show?id=2c9a5981483' target=_blank style='color:#2F92EE;'>#晚期卵巢癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59814, encryptionId=2c9a5981483, topicName=晚期卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/385F510BDFE0F55A4FFDFDFFD9892943/100, createdBy=a3262500163, createdName=siiner, createdTime=Thu Feb 27 09:41:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568603, encodeId=f854156860346, content=<a href='/topic/show?id=139f9658680' target=_blank style='color:#2F92EE;'>#铂类#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96586, encryptionId=139f9658680, topicName=铂类)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8eed15401054, createdName=fengxx, createdTime=Thu Feb 27 09:41:00 CST 2020, time=2020-02-27, status=1, ipAttribution=)]
    2020-04-14 jklm09
  6. 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2020, time=2020-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1315777, encodeId=f31f1315e7787, content=<a href='/topic/show?id=6f0188218ee' target=_blank style='color:#2F92EE;'>#葛兰素史克#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88218, encryptionId=6f0188218ee, topicName=葛兰素史克)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d58a435, createdName=sjq027, createdTime=Thu Feb 27 09:41:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394568, encodeId=a57e13945683c, content=<a href='/topic/show?id=2c9a5981483' target=_blank style='color:#2F92EE;'>#晚期卵巢癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59814, encryptionId=2c9a5981483, topicName=晚期卵巢癌)], attachment=null, 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  7. 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    2020-02-27 fengxx

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诺华制药宣布,美国食品药品监督管理局(FDA)接受了MET抑制剂卡马替尼(INC280)的新药申请(NDA)并给予了优先审查,用于一线治疗和先前治疗过的局部晚期或转移性MET外显子14跳跃(METex14)突变的非小细胞肺癌(NSCLC)患者。

前FDA局长和传染病专家警示:为新冠病毒大流行做准备, 保护医护人员

日前,FDA前任局长Scott Gottlieb博士和明尼苏达大学传染病研究与政策中心Dr. Michael Osterholm在接受媒体采访时表示,不再对全球控制新冠病毒疫情,避免大流行抱有任何乐观幻想了。随着越来越多国家,包括欧洲英国、意大利、亚洲伊朗、南韩、日本,越南等;非洲埃及等最新报告新增冠状病毒案例。两位业界权威人士认为美国现在唯一做的,也是必须立即做的是为更多确诊冠状病毒病例做好准备

FDA接受Karyopharm的口服核出口选择性抑制剂XPOVIO的补充新药申请,用于治疗复发或难治的弥漫性大B细胞淋巴瘤

Karyopharm Therapeutics宣布,美国食品药品监督管理局(FDA)已接受其补充新药申请(sNDA)寻求将口服核出口选择性抑制剂XPOVIO(selinexor)片剂,用于先前已接受过至少两种治疗方案的复发或难治的弥漫性大B细胞淋巴瘤(RR DLBCL)成年患者。FDA还批准了Karyopharm的优先审查请求。

FDA批准STAT3抑制剂WP1066治疗小儿脑癌试验的IND

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FDA批准了Agile Therapeutics每周一次的避孕贴片Twirla

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FDA批准CMN-001治疗晚期转移性肾细胞癌的IND

CoImmune制药公司今日宣布,FDA批准了CMN-001的研究性新药申请(IND),以推进CMN-001治疗晚期转移性肾细胞癌(mRCC)的IIb期临床试验。