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Bizengri

zenocutuzumab-zbco
Bispecific HER2/HER3 Antibody FDA Approved 2024 Merus
Route
IV
Half-Life
~12 days
FDA Approved
2024
Manufacturer
Merus
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1. Indications and Usage

NRG1 fusion-positive tumors: Unresectable/metastatic NRG1 fusion-positive solid tumors after prior systemic therapy.

2. Dosage and Administration

750 mg IV Q2W. Premedicate before first 2 infusions.

3. Dosage Forms and Strengths

Injection: 750 mg/15 mL vial

4. Contraindications

None listed.

5. Warnings and Precautions
  • Infusion-Related Reactions: 33%. Premedicate.
  • ILD/Pneumonitis: Permanently discontinue if confirmed.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Diarrhea (50%), Musculoskeletal Pain (43%), Fatigue (40%), Infusion Reactions (33%), Nausea (30%), Rash (30%), Dyspnea (25%), Edema (22%)

Diarrhea
50%
Musculoskeletal Pain
43%
Fatigue
40%
Infusion Reactions
33%
Nausea
30%
Rash
30%
Dyspnea
25%
Edema
22%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Not expected to interact via CYP enzymes.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Bispecific antibody binding HER2 and HER3, blocking NRG1 ligand binding and HER2/HER3 heterodimerization.

Pharmacokinetics

t½: ~10 days. Steady state by Cycle 4.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
FDA-Approved Tumor Types

Bizengri has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Tumor-agnostic indication — applies across multiple solid tumor types with qualifying biomarker.

External Resources
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Bizengri. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Bizengri (zenocutuzumab-zbco) approved for?

Bizengri (zenocutuzumab-zbco) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Bizengri (zenocutuzumab-zbco) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Bizengri (zenocutuzumab-zbco) work?

Bispecific antibody binding HER2 and HER3, blocking NRG1 ligand binding and HER2/HER3 heterodimerization.

What are the most common side effects?

Diarrhea (50%), Musculoskeletal Pain (43%), Fatigue (40%), Infusion Reactions (33%), Nausea (30%), Rash (30%), Dyspnea (25%), Edema (22%) Diarrhea 50% Musculoskeletal Pain 43% Fatigue 40% Infusion Reactions 33% Nausea 30% Rash 30% Dyspnea 25% Edema 22%