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These highlights do not include all the information needed to use HERNEXEOS safely and effectively. See full prescribing information for HERNEXEOS. HERNEXEOS® (zongertinib tablets), for oral use Initial U.S. Approval: 2025
Medication labelWhy this: Advisory · dailymed-prescription
HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- generic_name
- zongertinib
- product_names
- zongertinib
- ndc
- 0597-9257, 0597-9257-86, 0597-9257-59
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en