Targeted Therapy / Oncology

Bizengri (zenocutuzumab-zbco)

Merus N.V. / PTX Therapeutics · Bispecific Antibody — HER2 × HER3 Targeted Therapy

FDA Approved 2023 Intravenous (IV) infusion Specialty Medication
Bizengri zenocutuzumab-zbco injection 750mg vials and syringe, PTX Therapeutics specialty pharmacy

What is Bizengri? Bizengri (zenocutuzumab-zbco) is a bispecific antibody targeting HER2 and HER3. It is FDA-approved for adult patients with unresectable or metastatic NRG1 gene fusion-positive non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma following prior systemic therapy.

About Bizengri

Brand NameBizengri
Generic / INNzenocutuzumab-zbco
Drug ClassBispecific Antibody — HER2 × HER3 Targeted Therapy
ManufacturerMerus N.V. / PTX Therapeutics
AdministrationIntravenous (IV) infusion
FDA Approval2023
📦 750 mg/37.5 mL (20 mg/mL); carton contains two 375 mg/18.75 mL single-dose vials

FDA-Approved Uses for Bizengri

Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.

  • Unresectable or metastatic NRG1 gene fusion-positive non-small cell lung cancer (NSCLC) — after prior systemic therapy
  • Unresectable or metastatic NRG1 gene fusion-positive pancreatic adenocarcinoma — after prior systemic therapy
Biomarker Note: NRG1 gene fusion testing is REQUIRED for eligibility. Testing should be performed using an FDA-approved or validated assay. NRG1 fusions are rare — occurring in approximately 0.5–3% of NSCLCs and a small proportion of pancreatic cancers.

How Does Bizengri Work?

Zenocutuzumab is a bispecific antibody that simultaneously binds HER2 and HER3. NRG1 fusions produce aberrant neuregulin-1 (NRG1) protein that activates HER3 signaling. Bizengri blocks NRG1 from binding to HER3, preventing HER2:HER3 heterodimerization and downstream PI3K/AKT and MAPK signaling that drives tumor growth in NRG1 fusion-positive cancers.

Dosage & Administration

750 mg IV infusion every 2 weeks (Q2W) until disease progression or unacceptable toxicity. The prescribing oncologist determines dose modifications based on toxicity.

⚠️ Important

Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.

Warnings, Precautions & Side Effects

General Warning

Infusion-related reactions. Interstitial lung disease / pneumonitis. Embryo-fetal toxicity. Monitor left ventricular ejection fraction (LVEF).

⛔ Serious Warnings & Precautions
  • Infusion-related reactions
  • Interstitial lung disease / pneumonitis
  • Decreased LVEF
  • Embryo-fetal toxicity

Common Side Effects

  • Fatigue
  • Nausea
  • Diarrhea
  • Infusion-related reaction
  • Constipation
  • Decreased appetite
  • Peripheral edema

This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.

Storage & Handling

Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.

BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.

Insurance Coverage, Prior Authorization & Patient Assistance

🛡️ Commercial Insurance

Bizengri is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.

✅ Prior Authorization

Prior authorization is required by virtually all insurance plans for Bizengri. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.

🏥 Medicare Coverage

Medicare Part B covers this IV medication when administered in a clinical setting. Medicaid coverage varies by state.

🆓 Patient Assistance

Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.

Prior Authorization Patient Assistance Insurance & Savings Medication Costs

Frequently Asked Questions — Bizengri

Bizengri (zenocutuzumab-zbco) is a bispecific antibody targeting HER2 and HER3, approved for NRG1 gene fusion-positive non-small cell lung cancer and pancreatic adenocarcinoma after prior systemic therapy.

NRG1 (neuregulin-1) gene fusions are rare genomic alterations in which the NRG1 gene is fused to another gene, producing an abnormal protein that overstimulates HER3 signaling and drives tumor growth. NRG1 fusions occur in roughly 0.5–3% of NSCLCs.

Bizengri simultaneously binds HER2 and HER3, blocking the neuregulin-1 protein (produced by NRG1 fusions) from activating HER3. This prevents HER2:HER3 dimerization and shuts down downstream tumor growth signaling.

As a newer targeted oncology agent, Bizengri requires prior authorization from essentially all insurance plans. Coverage depends on NRG1 fusion documentation and the indication. BiologicHealthPlus can complete benefits verification and manage the PA process.

Yes. NRG1 gene fusion testing is required to determine eligibility. This is typically done via next-generation sequencing (NGS) of tumor tissue or liquid biopsy.

Related Medications

Keytruda (pembrolizumab)  ·  Trastuzumab (Herceptin)  ·  Pertuzumab (Perjeta)  ·  Gemcitabine

Related Conditions

NRG1 fusion-positive NSCLC  ·  NRG1 fusion-positive pancreatic cancer  ·  HER2/HER3 signaling tumors

Comparisons

Keytruda Gemcitabine

Authoritative References

Medical Disclaimer: This page is for general educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult your oncologist, hematologist, or licensed healthcare professional before making any treatment decisions. Last reviewed: August 2026 by the BiologicHealthPlus Clinical Team.