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Pemetrexed in Nonsquamous Non-Small-Cell Lung Cancer: The Billion Dollar Subgroup Analysis.
JAMA Oncology ( IF 28.4 ) Pub Date : 2018-01-01 , DOI: 10.1001/jamaoncol.2017.1944
Bishal Gyawali 1 , Vinay Prasad 2, 3, 4
Affiliation  

Pemetrexed (Alimta; Eli Lilly), a next-in-class antifolate drug, was first approved by the US Food and Drug Administration (FDA) in 2004 in combination with cisplatin for the treatment of pleural mesothelioma. This marketing authorization entailed a relatively small patient population, and through 2007, the drug’s sales never eclipsed $1 billion in a calendar year; 2008 marked the drug’s second approval, this time for the treatment of nonsquamous non–small-cell lung cancer (NSCLC). With this approval and perceived superiority in this histology, the use of pemetrexed skyrocketed, displacing older, cheaper cytotoxic drugs and earning Eli Lilly at least $1 billion annually for this medication.1 The approval of pemetrexed for lung cancer has been credited for the transformation of a rarely used cytotoxic drug to cancer therapy blockbuster,1 and data suggest pemetrexed was preferentially used over alternatives between 2007 and 2011.2 The Figure depicts rising sales of the drug over time. These stellar sales of pemetrexed may be credited, at least in part, to 2 subgroup analyses that showed improved overall survival (OS) in nonsquamous histology NSCLC but not squamous histology.3 However, several unusual observations about these findings raise the provocative question: Is the benefit in the nonsquamous histology real or spurious? If spurious, the use of pemetrexed may be one of the most common and costly medical practices driven by a subgroup finding in all of medicine.



中文翻译:

培美曲塞在非鳞状非小细胞肺癌中的应用:十亿美元亚组分析。

培美曲塞(Alimta; Eli Lilly)是一种下一代的抗叶酸药物,于2004年首次获得美国食品和药物管理局(FDA)的批准与顺铂联合用于胸膜间皮瘤的治疗。这项销售授权使患者人数相对较少,并且到2007年,该药物的销售额在一个日历年内从未超过10亿美元。2008年标志着该药的第二次批准,这次是用于治疗非鳞状非小细胞肺癌(NSCLC)。凭借这种认可和在组织学上的优越性,培美曲塞的使用激增,取代了较旧的,价格更便宜的细胞毒性药物,这种药物每年可为礼来赢得至少10亿美元的收入。1个培美曲塞用于肺癌的批准是因为一种罕见的细胞毒性药物向癌症治疗的重磅炸弹的转化[ 1],数据表明,培美曲塞在2007年至2011年之间优先于替代品使用。2该图显示了该药的销售随着时间的推移而增长。培美曲塞的这些恒星销售至少可以部分归功于2个亚组分析,这些亚组分析显示非鳞状组织学NSCLC改善了整体生存率(OS),但鳞状组织学却没有。3但是,关于这些发现的一些不同寻常的观察提出了一个挑衅性的问题:非鳞状组织学的益处是真实的还是虚假的?如果是假药,培美曲塞的使用可能是所有药物中亚组发现推动的最常见,最昂贵的医学实践之一。

更新日期:2018-01-11
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