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Zenocutuzumab is the first drug for cancers driven by NRG1 gene fusions, working by blocking HER3 from receiving its growth signal.
Zenocutuzumab is a HER2xHER3 bispecific antibody that docks on HER2 and physically blocks neuregulin 1 (NRG1) from binding HER3, the 'dock and block' mechanism that shuts off the growth signal in tumours driven by NRG1 gene fusions. It received accelerated approval in December 2024 for NRG1-fusion NSCLC and pancreatic cancer on the eNRGy trial, and in Q2 2026 the label was expanded to NRG1-fusion cholangiocarcinoma. It is given intravenously at 750 mg every 2 weeks; diarrhoea, musculoskeletal pain, fatigue and infusion reactions are the main adverse events. NRG1 fusions are rare and easily missed by DNA-only panels, so RNA-based sequencing is needed to find eligible patients, and confirmatory data are still required. Merus developed it and Partner Therapeutics commercialises it. For a newcomer: the first drug for a rare fusion that can appear in several different cancers.
Backbone ribbon from PDB 1IGT. RCSB PDB 1IGT. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
No public structure of zenocutuzumab; representative IgG shown.
1.One arm docks on HER2
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
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).
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.
Sources: NICE search: zenocutuzumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
Accelerated approval, NRG1-fusion NSCLC and pancreatic adenocarcinoma (eNRGy): first therapy for NRG1 fusions The confirmatory requirement was still open 1.8 years later, when the FDA's table was read. source
Treatment of adults with advanced unresectable or metastatic nonsmall cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.8 years later, when the FDA's table was read. source
NRG1-fusion cholangiocarcinoma source
| 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.
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Every KRAS wild-type pancreatic cancer should be tested for NRG1 fusions because a specific, approved antibody now exists; zenocutuzumab is the first targeted drug approved for a pancreatic cancer driver.
Together with the German MASTER report, this paper is why guidelines recommend comprehensive profiling with fusion detection in KRAS wild-type pancreatic cancer.
KRAS wild-type status should trigger fusion testing, ideally by RNA sequencing, because NRG1 fusions can be targeted by HER-family inhibitors and now by zenocutuzumab.
Query 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.
Shares NRG1 gene fusion, NRG1, Receptor tyrosine kinase activation, HER2.
Shares NRG1 gene fusion, NRG1, Receptor tyrosine kinase activation, HER2.
Shares eNRGy: efficacy of zenocutuzumab in NRG1 fusion-positive cancer, Jones 2019: NRG1 gene fusions are recurrent, clinically actionable rearrangements in KRAS wild-type pancreatic ductal adenocarcinoma, Heining 2018: NRG1 fusions in KRAS wild-type pancreatic cancer, Pancreatic ductal adenocarcinoma.
Shares eNRGy: efficacy of zenocutuzumab in NRG1 fusion-positive cancer, KRAS wild-type pancreatic ductal adenocarcinoma, Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Metastatic pancreatic ductal adenocarcinoma.
Shares Jones 2019: NRG1 gene fusions are recurrent, clinically actionable rearrangements in KRAS wild-type pancreatic ductal adenocarcinoma, Heining 2018: NRG1 fusions in KRAS wild-type pancreatic cancer, HER2, Lung cancer (all types).
Shares HER3, Receptor tyrosine kinase activation, HER2.
Shares NRG1, KRAS wild-type pancreatic ductal adenocarcinoma, Receptor tyrosine kinase activation, HER2.
Shares Pancreatic cancer drugs in England: NICE appraisals and the Cancer Drugs Fund (September 2026), KRAS wild-type pancreatic ductal adenocarcinoma, Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Metastatic pancreatic ductal adenocarcinoma.