Ag(e)nostic precision oncology therapy approvals across the years. Trends Cancer 2025 Aug;11(8):726-735
Date
06/07/2025Pubmed ID
40480903Pubmed Central ID
PMC12350067DOI
10.1016/j.trecan.2025.04.015Scopus ID
2-s2.0-105007440053 (requires institutional sign-in at Scopus site) 1 CitationAbstract
Precision oncology leverages targetable molecular aberrations to treat cancer. Initially, use of these therapies required biomarker detection in a specific tumor type. Recently, regulatory agencies have approved highly active biomarker-based, tumor-agnostic therapies, which are crucial for the unmet needs of patients with rare cancer, including children with cancer, because an infrequent biomarker in an already rare cancer represents a prohibitive clinical trial accrual barrier. There are also now several 'ag(e)nostic' precision oncology therapies - agnostic to tumor type and also approved for all ages. In this opinion, we provide historical context for the precision oncology field and contend that, moving forward, ag(e)nostic precision oncology approvals should be the norm for this class of therapeutics rather than an exception to the rule.
Author List
Kudek MR, Adashek JJ, Kurzrock RAuthors
Matthew Kudek MD Assistant Professor in the Pediatrics department at Medical College of WisconsinRazelle Kurzrock MD Center Associate Director, Professor in the Medicine department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
Antineoplastic AgentsBiomarkers, Tumor
Clinical Trials as Topic
Drug Approval
History, 21st Century
Humans
Medical Oncology
Molecular Targeted Therapy
Neoplasms
Precision Medicine
United States Food and Drug Administration
