$Clovis肿瘤药物(CLVS)$
①2016年12月 卵巢癌 Approved（三线及以上，BRCAm）；获批是基于一项Ⅰ/Ⅱ期研究数据。后续进行ARIEL4 Ⅲ期验证性研究；
②2018年4月 卵巢癌（二线维持）Approved，regardless of BRCA status；
③BRCAm mCRPC三线获批；
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ATHENA-MONO（卵巢癌一线维持）达到终点；
TRITON3 III期临床（mCRPC二线，招募患者条件同PROfound III），top-line data are now expected in the third quarter of 2022；
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在欧洲，第一个适应症有些问题现在，但是管理层强调这个适应症占比营收不大，并且ARIEL4的最终OS结果，铂类敏感亚群的OS HR 1.07，与奥拉帕利在SOLO3中的HR 1.07完全一致。
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讲道理，适应症的范围以及进度，不算太差，但是为啥营收这么差呢。。。。营销不行？小公司的宿命吗？
$恒瑞医药(SH600276)$ $再鼎医药(ZLAB)$
全部讨论
故事讲多了，就变成事故了。。。
就在几周前，克洛维思公司(Clovis)还在全力宣传其发育迟缓的现金牛鲁布拉卡(Rubraca)在一项卵巢癌III期研究中取得了重大胜利。现在，你可以登陆美国证券交易委员会(SEC)的网站，看看该公司伤痕累累的股价为何再次遭受重挫。
In a public setting, Clovis CEO Patrick Mahaffy touted a win on progression-free survival as a frontline maintenance therapy for ovarian cancer. That would be the basis of an sNDA at the FDA — setting up a potential near-term advance for the biotech, which has suffered along with the number 3 PARP on the market.
The problem is the FDA isn’t being won over on PFS data, according to Clovis. They want mature OS data — and we find that the agency specified at least 50% mature OS data — which Clovis estimates won’t be available for another 2 years, “and if we do choose to submit prior to that, we should expect the FDA to require a discussion at an ODAC meeting in connection with its review of such sNDA submission.”
“This recommendation by the FDA was also influenced by their interpretation of the ARIEL4 survival data,” says Clovis.
Lynparza和尼拉帕利都是凭借PFS数据申报的。。。所谓一时慢，处处慢啊。。。