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Agnostic Biomarkers in Molecular Pathology.

Zeynep Sagnak Yilmaz1,2, Yasemin Cakir1, Sibel Demir Kececi1,3

  • 1Department of Molecular Pathology, Dokuz Eylül University Graduate School of Health Sciences, İzmir, Türkiye.

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|November 19, 2025
PubMed
Summary

Tumor-agnostic therapies target specific molecular alterations, not cancer type. Approved biomarkers include MSI, NTRK, TMB, BRAF V600E, and RET fusions, with ongoing research for new targets.

Keywords:
Agnosticbiomarkermicrosatellite instabilityneurotrophic tyrosine receptor kinasetumor mutation burden

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Area of Science:

  • Oncology
  • Molecular Biology
  • Genetics

Background:

  • Molecular alterations drive cancer cell behavior and are crucial for diagnosis and targeted therapy development.
  • Identifying common targetable mutations across diverse tumor types has enabled the rise of tumor-agnostic therapies.
  • Five biomarkers are currently approved for tumor-agnostic therapy: microsatellite instability (MSI), neurotrophic tyrosine receptor kinase (NTRK) fusions, tumor mutation burden (TMB), BRAF V600E mutation, and rearranged during transfection (RET) fusions.

Purpose of the Study:

  • To review the current landscape of approved tumor-agnostic biomarkers and therapies.
  • To highlight the significance of molecular alterations in guiding cancer treatment decisions.
  • To discuss ongoing research into novel molecular targets for future agnostic therapies.

Main Methods:

  • Literature review of FDA-approved tumor-agnostic biomarkers and therapies.
  • Analysis of studies identifying common molecular alterations across various cancer types.
  • Examination of ongoing research into potential new agnostic biomarkers.

Main Results:

  • The FDA has approved specific therapies for MSI-high/TMB-high tumors (pembrolizumab), NTRK fusions (larotrectinib, entrectinib), BRAF V600E mutations (dabrafenib/trametinib), and RET fusions (selpercatinib).
  • These approvals represent a significant milestone in personalized cancer treatment.
  • The efficacy of agnostic therapy relies on identifying new, actionable biomarkers.

Conclusions:

  • Tumor-agnostic therapies represent a paradigm shift in cancer treatment, focusing on molecular profiles rather than tumor origin.
  • Continued research into biomarkers like PD-L1, KRAS, NRG1, FGFR, ALK, AKT, HER2, PIK3CA, and BRCA is essential for expanding agnostic treatment options.
  • Identifying new agnostic biomarkers will enhance positive responses to these targeted therapies.