FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option


1 HERNEXEOS Prescribing Information.  
2 Baraibar I, et al. Novel drugs targeting EGFR and HER2 exon 20 mutations in metastatic NSCLC. Crit Rev Oncol Hematol. 2020;148:102906.
3 Li, B.T. et al. Trastuzumab Deruxtecan in HER2-Mutant Non–Small-Cell Lung Cancer. N Engl J Med. 2022;386:241–51.
4 Zeng J, Ma W, Young RB, Li T. Targeting HER2 genomic alterations in non-small cell lung cancer. J Natl Cancer Cent. 2021;1(2):58-73.
5 International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: https://gco.iarc.fr/tomorrow/en (Accessed: November 2025).
6 Casal-Mouriño, A. et al. Epidemiology of stage III lung cancer: frequency, diagnostic characteristics, and survival. Transl Lung Cancer Res. 2021;10(1):506-518
7 National Cancer Institute. Surveillance, Epidemiology, and End Results (SEER). 5-Year Survival Rates. Available at: https://www.seer.cancer.gov/csr/1975_2016/results_merged/topic_survival.pdf (Accessed: November 2025).
8 Valentine, T. R. et al. Illness Perceptions and Psychological and Physical Symptoms in Newly Diagnosed Lung Cancer. Health Psychol. 2022;41(6): 379–388.
9 Andersen, B. L. et al. Newly diagnosed patients with advanced non-small cell lung cancer: A clinical description of those with moderate to severe depressive symptoms. Lung Cancer. 2020;145:195-204.
10 Presley, C. J. et al. Functional Disability Among Older Versus Younger Adults With Advanced Non–Small-Cell Lung Cancer. JCO  Oncol Pract. 2021;17(6):e848–e858.
11 Wilding B, Woelflingseder L, Baum A, et al. Zongertinib (BI 1810631), an Irreversible HER2 TKI, Spares EGFR Signaling and Improves Therapeutic Response in Preclinical Models and Patients with HER2-Driven Cancers. Cancer Discov. 2025;15(1):119-138. doi:10.1158/2159-8290.CD-24-0306



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