The hallmarks of tissue-agnostic therapies and strategies for early anticancer drug discovery

• Tissue-agnostic therapy is a new branch of biomarker-centric cancer care. • We introduce the current therapeutic paradigm shift toward tissue-agnostic treatment. • We propose five hallmarks of tissue-agnostic treatments. • We discuss tissue-agnostic strategies for drug development. Recently, precision medicine has enabled biomarker-driven treatment to be administered in a pan-tumor setting, so-called tissue-agnostic therapy. This represents a paradigm shift in cancer care from conventional cancer type-specific to biomarker-centric care, where patients are selected for this type of therapy based on molecular aberrations that occur across cancer types, regardless of tumor site or histology. This approach is particularly important because it offers new treatment options for patients with rare cancers or for whom there are no adequate treatments. Therefore drug development with the goal of tissue agnosticism can accelerate drug approval and address unmet medical needs. Herein, we discuss our opinions on the hallmarks of tissue-agnostic treatments and propose strategies for early drug discovery based on these hallmarks.