Zenocutuzumab-Zbco Application Scope

Treatment of adults with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion, with disease progression on or after prior systemic therapy.
Treatment of adults with advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring an NRG1 gene fusion, with disease progression on or after prior systemic therapy.

These indications are approved under the FDA’s Accelerated Approval Program, contingent upon verification of clinical benefit in confirmatory trials.

Zenocutuzumab-Zbco Characteristics

Specification: 375 mg/18.75 mL (20 mg/mL) per single-dose vial

Ingredients:

Active: Zenocutuzumab-zbco
Inactive: Histidine, L-histidine hydrochloride monohydrate, polysorbate 20, trehalose, water for injection

Properties:

Humanized bispecific IgG1k antibody targeting HER2 and HER3
Inhibits HER2:HER3 dimerization and prevents NRG1 binding to HER3
Mediates antibody-dependent cellular cytotoxicity (ADCC)

Packaging Specification: Two vials (each 375 mg) per carton

Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.

Expiry Date: Refer to the manufacturer’s labeling for specific expiration information.

Executive Standard: Refer to the manufacturer’s labeling for detailed standards.

Approval Number: FDA approval granted on December 4, 2024

Date of Revision: December 2024

Manufacturer: Merus N.V., Uppsalalaan 17, Utrecht, The Netherlands

Guidelines for the Use of Zenocutuzumab-Zbco

Dosage and Administration:

Recommended dose: 750 mg administered as an intravenous infusion every 2 weeks until disease progression or unacceptable toxicity
Administer over 4 hours after dilution
Premedications prior to each infusion to reduce the risk of infusion-related reactions:
- Dexamethasone 10 mg (oral or IV)
- Acetaminophen 1,000 mg (oral or IV)
- Dexchlorpheniramine 5 mg or equivalent H1 antihistamine (oral or IV)

Adverse Reactions:

Common adverse reactions (≥10%):
- Diarrhea
- Musculoskeletal pain
- Fatigue
- Nausea
- Infusion-related reactions
- Dyspnea
- Rash
- Constipation
- Vomiting
- Abdominal pain
- Edema
Serious adverse reactions:
- Infusion-related reactions/hypersensitivity/anaphylaxis
- Interstitial lung disease/pneumonitisMayo
- Left ventricular dysfunction
- Embryo-fetal toxicity

Contraindications:

None reported

Precautions:

Monitor for infusion-related reactions; administer in a setting equipped for emergency management
Evaluate left ventricular ejection fraction (LVEF) before initiating treatment and monitor periodically
Advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose
Advise against breastfeeding during treatment and for 2 months after the last dose

Zenocutuzumab-Zbco Interactions

Drug Interactions:

Live vaccines: Use of live vaccines (e.g., measles, mumps, rubella, varicella, yellow fever) is not recommended during treatment due to potential interactions.
Inform healthcare providers of all medications, including prescription, over-the-counter, vitamins, and herbal supplements, as interactions may occur.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.