Zongertinib
Zongertinib was the first oral HER2 inhibitor for lung cancer with HER2 mutations, approved in 2025 and moved to first line in 2026.
Beamion LUNG-1 (ORR ~71% in previously treated HER2-mutant NSCLC) led to accelerated approval August 2025; Q1 2026 first-line approval. Boehringer Ingelheim. Competes with T-DXd and sevabertinib (Bayer, approved late 2025).
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral
- Schedule
- 120 mg once daily
- Dose modifications
- Reduce for hepatotoxicity, diarrhoea
- Monitoring
- LFTs, LVEF, respiratory symptoms
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Boehringer Ingelheim patient support
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: zongertinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- Mar 2024DesignationUS
Breakthrough Therapy designation source
- 8 Aug 2025ApprovalUS
Accelerated approval, previously treated HER2-mutant non-squamous NSCLC (Beamion LUNG-1) source
- Q1 2026ApprovalUS
First-line HER2-mutant non-squamous NSCLC source
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
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