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These highlights do not include all the information needed to use HYRNUO safely and effectively. See full prescribing information for HYRNUO. HYRNUO® (sevabertinib) tablets, for oral use Initial U.S. Approval: 2025
Medication labelWhy this: Advisory · dailymed-prescription
HYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)], and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) [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
- sevabertinib
- product_names
- SEVABERTINIB
- ndc
- 50419-397, 50419-397-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en