The significance of tissue-agnostic biomarkers in solid tumors: the more the merrier?

IntroductionTo 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.Areas coveredAlthough 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.Expert opinionTo 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.

Automated summary

Several emerging biomarkers in predictive molecular oncology have gained interest in precision medicine. However, crucial issues related to diagnosis and therapy need to be addressed in the tissue-agnostic model. This review critically examines the role of tissue-agnostic biomarkers in solid tumors and highlights the challenges in detection and drug approval.