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Zongertinib
Topic: Chemistry
From HandWiki - Reading time: 5 min
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]
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]
Zongertinib is sold under the brand name Hernexeos.[2][6]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 Cite error: Invalid
<ref>tag; no text was provided for refs namedHernexeos FDA label - ↑ 2.0 2.1 2.2 "Novel Drug Approvals for 2025". 8 August 2025. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025.
This article incorporates text from this source, which is in the public domain.
- ↑ "HER2 in Non-Small Cell Lung Cancer (NSCLC): Evolution of the Therapeutic Landscape and Emerging Drugs-A Long Way to the Top". Molecules (Basel, Switzerland) 30 (12): 2645. June 2025. doi:10.3390/molecules30122645. PMID 40572608.
- ↑ "HER2 alterations in non-small cell lung cancer (NSCLC): from biology and testing to advances in treatment modalities". Frontiers in Oncology 15. 2025. doi:10.3389/fonc.2025.1624124. PMID 40620714.
- ↑ 5.0 5.1 5.2 5.3 5.4 5.5 "FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations". 8 August 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations. This article incorporates text from this source, which is in the public domain.
- ↑ 6.0 6.1 "U.S. FDA grants accelerated approval to Boehringer's Hernexeos as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC" (Press release). Boehringer Ingelheim. 8 August 2025. Retrieved 10 August 2025 – via GlobeNewswire.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 90". WHO Drug Information 37 (3). 2023.
- ↑ "Zongertinib". https://searchusan.ama-assn.org/finder/usan/search/MN-24/relevant/1/.
External links
- "Zongertinib ( Code - C199022 )". https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C199022.
- Clinical trial number NCT04886804 for "Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)" at ClinicalTrials.gov
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