Zongertinib

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]

## Contents

* 1 Medical uses
* 2 Adverse effects
* 3 History
* 4 Society and culture
* 4.1 Legal status
* 4.2 Names
* 5 References
* 6 External links

## 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. ↑ 1.0 1.1 1.2 1.3 1.4 Cite error: Invalid `<ref>` tag; no text was provided for refs named `Hernexeos FDA label`
2. ↑ 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.
3. ↑ "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.
4. ↑ "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. ↑ 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. ↑ 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.
7. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 90". WHO Drug Information 37 (3). 2023.
8. ↑ "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

* v
* t
* e

Targeted cancer therapy / antineoplastic agents (L01)

CI monoclonal antibodies ("-mab")|

| Receptor tyrosine kinase|

* ErbB: HER1/EGFR (Cetuximab
* Panitumumab)
* HER2/neu (Trastuzumab
* Trastuzumab emtansine)

|

Others for solid tumors|

* EpCAM (Catumaxomab
* Edrecolomab)
* VEGF-A (Bevacizumab)

Leukemia/lymphoma|

* lymphoid: CD20 (Ibritumomab
* Obinutuzumab
* Ofatumumab
* Rituximab
* Tositumomab), CD30 (Brentuximab), CD52 (Alemtuzumab)

* myeloid: CD33 (Gemtuzumab)

Tyrosine kinase inhibitors ("-nib")|

| Receptor tyrosine kinase|

* ErbB: HER1/EGFR (Brigatinib
* Dacomitinib
* Erlotinib
* Gefitinib
* Olmutinib
* Osimertinib
* Rociletinib
* Vandetanib)
* HER1/EGFR and HER2/neu
* Afatinib
* Lapatinib
* Neratinib

* RTK class III: C-kit and PDGFR (Axitinib
* Masitinib
* Pazopanib
* Sorafenib
* Sunitinib
* Toceranib)
* FLT3 (Lestaurtinib)

* VEGFR
* Axitinib
* Cediranib
* Lenvatinib
* Nintedanib
* Pazopanib
* Regorafenib
* Semaxanib
* Sorafenib
* Sunitinib
* Tivozanib
* Toceranib
* Vandetanib

* ALK
* Alectinib
* Brigatinib
* Ceritinib
* Crizotinib

RET inhibitors: Vandetanib (also VEGFR and EGFR). Entrectinib (ALK, ROS1, NTRK). c-MET inhibitor: Cabozantinib (also VEGFR2).

|

Non-receptor|

* bcr-abl
* Bosutinib
* Dasatinib
* Imatinib
* Nilotinib
* Ponatinib
* Radotinib

* Src (Bosutinib
* Dasatinib)

* Janus kinase
* Lestaurtinib
* Momelotinib
* Pacritinib
* Ruxolitinib

* MAP2K
* Binimetinib
* Cobimetinib
* Selumetinib
* Trametinib

* EML4-ALK
* Crizotinib
* Entrectinib
* Lorlatinib

* Bruton's
* Acalabrutinib
* Ibrutinib

Other|

* fusion protein against VEGF (Aflibercept)
* proapoptotic peptide against ANXA2 and prohibitin (Adipotide)
* exotoxin against IL-2 (Denileukin diftitox)
* mTOR inhibitors
* Everolimus
* Temsirolimus
* hedgehog inhibitors
* Sonidegib
* Vismodegib
* CDK inhibitor (Palbociclib
* Ribociclib)

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