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Zongertinib was the first oral HER2 inhibitor for lung cancer with HER2 mutations, approved in 2025 and moved to first line in 2026.
Zongertinib is an irreversible HER2-selective tyrosine kinase inhibitor that spares EGFR, which limits the rash and diarrhoea seen with pan-HER inhibitors; it is taken as 120 mg once daily. Beamion LUNG-1 showed a response rate of about 71% in previously treated HER2-mutant NSCLC, leading to accelerated approval in August 2025, and in Q1 2026 it was approved as first-line therapy for HER2-mutant non-squamous NSCLC, the first oral HER2 inhibitor for this setting. Boehringer Ingelheim developed it. Diarrhoea, rash, raised liver enzymes, nausea and fatigue are the main adverse events. It competes with trastuzumab deruxtecan and with sevabertinib (Bayer, approved late 2025), and the best sequence between a pill and an antibody-drug conjugate is unresolved. For a newcomer: the first pill for lung cancers driven by HER2 mutations.
Irreversible HER2-selective TKI sparing EGFR. Connects to HER2.
1.Oral drug is absorbed and reaches the tumour
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). FDA accelerated approval 2025 for HER2-mutant NSCLC.
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. HER2 (ERBB2) activating mutation by an approved test.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE search: zongertinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Breakthrough Therapy designation source
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 approved test, and who have received prior systemic therapy
Accelerated approval, previously treated HER2-mutant non-squamous NSCLC (Beamion LUNG-1) The confirmatory requirement was still open 1.1 years later, when the FDA's table was read. source
First-line HER2-mutant non-squamous NSCLC source
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
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 0.6 years later, when the FDA's table was read. source
| Region | Year | Indication |
|---|---|---|
| US | 2025 | HER2-mutant NSCLC, previously treated (accelerated) |
| US | 2026 | First-line HER2-mutant non-squamous NSCLC |
| Adverse event |
|---|
| Diarrhoea |
| Rash |
| ALT/AST increased |
| Nausea |
| Fatigue |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Zongertinib" OR ABSTRACT:"Zongertinib" OR TITLE:"Hernexeos" OR ABSTRACT:"Hernexeos") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Zongertinib, not a curated reading list.
Shares Sevabertinib, HER2-mutant non-small-cell lung cancer, HER2, Small-molecule kinase inhibitors.
Shares Sevabertinib, HER2-mutant non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer.
Shares HER2 (ERBB2) activating mutation, Receptor tyrosine kinase activation, Lung cancer (all types), Non-small-cell lung cancer.
Shares HER2 (ERBB2) activating mutation, Non-small cell lung cancer (KEGG map), Receptor tyrosine kinase activation, HER2.
Shares Boehringer Ingelheim, Lung cancer (all types), Small-molecule kinase inhibitors, Non-small-cell lung cancer.
Shares Beamion LUNG-1, HER2-mutant non-small-cell lung cancer, Non-small-cell lung cancer.
Shares Boehringer Ingelheim, HER2-mutant non-small-cell lung cancer, HER2, Lung cancer (all types).
Shares HER2 (ERBB2) activating mutation, Receptor tyrosine kinase activation, HER2, Lung cancer (all types).