迄今为止，在预测性分子肿瘤学领域中，已经出现了几种新兴生物标志物，引起了相当大的兴趣。精准医学的出现导致了能够独立于组织学，针对罕见分子途径开发创新药物的发展，被定义为无组织特异性药物。尽管在肿瘤学场景中，这种新的无组织特异性模式有很大的前景，但在诊断和治疗方面存在一些关键问题。本综述旨在批判性地审查无组织特异性生物标志物在不同实体瘤中的作用，重点是探讨无组织特异性生物标志物的患病率和检测方法，以及药物的批准情况，以指导临床医生在这个不断发展的领域中。为加强无组织特异性批准的框架，应加强监管、产业和学术界之间的对话。关键问题包括开发一个能够克服患者纳入标准的异质性和越来越难解释的下一代测序（NGS）分析技术的高效网络系统。在国家环境中，需要进行成本效益和风险效益研究，考虑到诊断测试和治疗报销的方式。

To date, several emerging biomarkers have gained considerable interest in the field of predictive molecular oncology. The advent of precision medicine has led to the development of innovative drugs targeting rare molecular pathways independently from histology, defined as tissue-agnostic drugs.Although there is a lot of promise for this new tissue-agnostic model in the oncological scenario, crucial issues from both the diagnostic and therapeutic standpoint are emerging. This review aims to critically examine the role of tissue-agnostic biomarkers in different solid tumors, focusing on the prevalence and methods of detection of agnostic biomarkers together with drug approvals to guide clinicians in this evolving landscape.To strengthen the framework for tissue-agnostic approvals, the dialogue between regulatory, industrial, and academic parties should be intensified. Critical questions include the development of an efficient network system that can overcome the heterogeneity of patients' inclusion criteria along with the increasingly difficult interpretation of next-generation sequencing (NGS) profiling technologies. Cost-effectiveness and risk-benefit studies are needed in the national context considering the modalities of access to diagnostic tests and reimbursement of treatments.