A remarkable year for NSCLC: Seven new FDA approvals in 2025 across molecular targets

Krešimir Tomić; Semir Vranić

doi:10.17305/bb.2026.13832

Authors

Krešimir Tomić Department of Oncology, University Hospital Center Mostar, Mostar, Bosnia and Herzegovina https://orcid.org/0000-0003-0841-4497
Semir Vranić College of Medicine, QU Health, Qatar University, Doha, Qatar https://orcid.org/0000-0001-9743-7265

DOI:

https://doi.org/10.17305/bb.2026.13832

Keywords:

NSCLC, precision oncology, biomarker-driven therapy, ADC, TKI

Abstract

Non-small cell lung cancer (NSCLC) remains the leading cause of cancer mortality worldwide; however, precision oncology has fundamentally transformed its treatment landscape. In 2025, seven approvals by the U.S. Food and Drug Administration (FDA) further accelerated biomarker-driven care across critical molecular subsets. These include MET-directed and trophoblast cell-surface antigen-2 (TROP-2) antibody-drug conjugates (ADCs), expanded strategies targeting epidermal growth factor receptor (EGFR), notably those addressing exon 20 insertion mutations, a ROS proto-oncogene 1 (ROS1) inhibitor, and various human epidermal growth factor receptor 2 (HER2) options that encompass both tumor-agnostic and mutation-selected approaches. These advancements underscore the necessity for integrated diagnostics—such as next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), and immunohistochemistry (IHC)—while also emphasizing ongoing challenges in biomarker selection, therapeutic sequencing, and equitable global implementation.

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