Zongertinib
Medication
From Wikipedia, the free encyclopedia
Zongertinib, sold under the brand name Hernexeos, is an anti-cancer medication used for the treatment of non-small cell lung cancer.[1][2] Zongertinib is a kinase inhibitor of human epidermal growth factor receptor 2 (HER2).[1][3][4] It is taken by mouth.[1]
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| Trade names | Hernexeos |
| Other names | BI-1810631, BI1810631 |
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| Routes of administration | By mouth |
| Drug class | Antineoplastic, epidermal growth factor receptor 2 (HER2) inhibitor |
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| Formula | C29H29N9O2 |
| Molar mass | 535.612 g·mol−1 |
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Zongertinib was approved for medical use in the United States in August 2025.[5]
Medical uses
Zongertinib is indicated for the treatment of adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.[1][5]
Adverse effects
The US Food and Drug Administration prescribing information includes warnings and precautions for hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.[1][5]
History
Efficacy was evaluated in participants with unresectable or metastatic, non-squamous non-small cell lung cancer with HER2 (ERBB2) TKD mutations who had received prior systemic therapy and received zongertinib in Beamion LUNG-1 (NCT04886804), an open-label, multi-center, multi-cohort trial.[5] The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) determined by blinded independent central review per RECIST v1.1.[5]
The US Food and Drug Administration granted the application for zongertinib priority review, breakthrough therapy, and fast track designations.[5]
Society and culture
Legal status
Zongertinib was approved for medical use in the United States in August 2025.[2][6]
Names
Zongertinib is the international nonproprietary name[7] and the United States Adopted Name.[8]
