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目标驱动的组织-不可知药物批准-药物开发的新途径

Kyaw Z Thein^1,2,3, Yin M Myat^4,5, Byung S Park^6,7

¹Division of Hematology and Medical Oncology, Comprehensive Cancer Centers of Nevada-Central Valley, 3730 S Eastern Ave, Las Vegas, NV 89169, USA.

|July 27, 2024

概括

瘤不可知疗法针对多种癌症类型的共同基因组生物标志物,从传统的基于组织学的药物开发转变. 这种方法导致了8个FDA批准,包括向疗法和免疫检查点抑制剂.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.
基因组学就是基因组学.

背景情况:

传统的癌症药物开发依赖于基于组织学的分类.
瘤不可知药物开发的目标是共同的基因组生物标志物,无论瘤来源如何.
这种范式转变需要对传统药物开发途径进行重新评估.

研究的目的:

审查目前的瘤不可知疗法批准的情况.
突出关键的基因组生物标记物和向药物在瘤无知药物开发中的向药物.
强调识别和开发泛癌疗法的重要性.

主要方法:

审查食品和药物管理局 (FDA) 对瘤不可知疗法的批准.
分析临床试验设计,如篮子试验,以评估泛癌疗效.
识别特定的基因组生物标志物 (例如MSI-H/dMMR,NTRK融合,RET融合,BRAF突变,HER2阳性) 和相关药物.

主要成果:

美国食品和药物管理局已经批准了八种瘤不可知疗法.
已批准的疗法包括免疫检查点抑制剂 (例如Pembrolizumab,Dostarlimab) 和向药物 (例如Larotrectinib,Entrectinib,Selpercatinib,Dabrafenib/Trametinib,Fam-trastuzumab deruxtecan-nxki).
这些批准的目标是生物标志物,如微卫星不稳定性高 (MSI-H),缺陷不匹配修复 (dMMR),NTRK融合,RET融合,BRAF突变和HER2阳性.

结论:

瘤不可知药物开发为基于组织学的方法提供了一个有希望的替代方案.
篮子试验有助于评估针对不同癌症的常见生物标志物的药物.
持续的研究和开发对于扩大瘤不可知疗法的临床益处至关重要.

关键词:

病毒性瘤基因同类B V600E (BRAFV600E) 的V-Raf小鼠肉瘤病毒.达布拉费尼布和特拉美丁尼布的使用提供了limab-gxlyly 的产品.恩德雷克提尼布 (Entrectinib) 是一种药物.拉洛特雷克提尼布 (Larotrectinib) 是一种药物.微卫星的不稳定性高 (MSI-H).神经变型氨酸激酶 (NTRK) 的作用.这就是Pembrolizumab.精确瘤学精确瘤学在转染过程中重新排列 (RET).塞尔珀卡提尼布 (selpercatinib) 是一种可以组织不可知药物开发组织不可知药物开发瘤突变负担高 (TMB-H) 的情况

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