Zenocutuzumab
Zenocutuzumab is the first drug for cancers driven by NRG1 gene fusions, working by blocking HER3 from receiving its growth signal.
Accelerated approval December 2024 for NRG1-fusion NSCLC and pancreatic cancer (eNRGy trial); Q2 2026 expanded to NRG1-fusion cholangiocarcinoma. Merus/Partner Therapeutics.
No public structure of zenocutuzumab; representative IgG shown.
1.One arm docks on HER2
- Route
- IV infusion
- Schedule
- 750 mg every 2 weeks
- Dose modifications
- Hold for infusion reactions and LVEF decline
- Monitoring
- LVEF; infusion reactions; embryo-fetal toxicity
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 B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. FDA accelerated approval for NRG1 fusion-positive NSCLC and pancreatic cancer (2024).
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. NRG1 fusion must be documented by an approved NGS assay.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). 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: zenocutuzumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 4 Dec 2024ApprovalUS
Accelerated approval, NRG1-fusion NSCLC and pancreatic adenocarcinoma (eNRGy): first therapy for NRG1 fusions source
- Q2 2026ApprovalUS
NRG1-fusion cholangiocarcinoma source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | NRG1-fusion NSCLC and pancreatic adenocarcinoma |
| US | 2026 | NRG1-fusion cholangiocarcinoma |
| Adverse event |
|---|
| Diarrhoea |
| Musculoskeletal pain |
| Fatigue |
| Nausea |
| Infusion-related reactions |
| Dyspnoea |
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 B (physician-administered); commercial plans per formulary | 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:"Zenocutuzumab" OR ABSTRACT:"Zenocutuzumab" OR TITLE:"Bizengri" OR ABSTRACT:"Bizengri") 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 Zenocutuzumab, not a curated reading list.