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Concerning FDA approval of trilaciclib (Cosela) in extensive-stage small-cell lung cancer
Translational Oncology ( IF 4.5 ) Pub Date : 2021-08-19 , DOI: 10.1016/j.tranon.2021.101206
Kerrington Powell 1 , V Prasad 2
Affiliation  

Trilaciclib is a recently approved cyclin-dependent kinase 4/6 inhibitor that is designed to decrease the incidence of chemotherapy-induced myelosuppression in adult patients with extensive-stage small-cell lung cancer receiving chemotherapy. Currently, this first-in-class therapy raises two open issues: its bio-plausibility and paucity of evidence demonstrating a lasting impact on clinical endpoints. Based on the existing phase 2 data, trilaciclib appears to be a therapy that can make a positive impact by preventing myelosuppression, but empirical validation with larger phase III trials should be conducted to confirm these benefits. The purpose of this article is to facilitate discussion about the role of trilaciclib in clinical practice and the need for additional trials.



中文翻译:

关于 FDA 批准 trilaciclib (Cosela) 治疗广泛期小细胞肺癌

Trilaciclib 是最近批准的细胞周期蛋白依赖性激酶 4/6 抑制剂,旨在降低接受化疗的广泛期小细胞肺癌成人患者化疗引起的骨髓抑制的发生率。目前,这种一流的疗法提出了两个悬而未决的问题:其生物合理性和缺乏证据表明对临床终点有持久影响。根据现有的 2 期数据,trilaciclib 似乎是一种可以通过预防骨髓抑制产生积极影响的疗法,但应通过更大规模的 III 期试验进行实证验证以确认这些益处。本文的目的是促进关于 trilaciclib 在临床实践中的作用以及额外试验的必要性的讨论。

更新日期:2021-08-20
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