Last reviewed 2026-05-23 · How we verify

Bizengri (ZENOCUTUZUMAB)

Bizengri (generic name: ZENOCUTUZUMAB) is a Monoclonal antibody drug developed by Merus N.V.. It is currently FDA-approved (first approved 2025) for advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion, advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion.

Bizengri works by binding to a specific protein on cancer cells to block their growth and spread.

Bizengri is an antibody that inhibits the ErbB-2/ErbB-3 heterodimer. It is classified as an inhibitor and works by targeting the ErbB-2/ErbB-3 heterodimer.

At a glance

Mechanism of action

Zenocutuzumab-zbco is a bispecific antibody that binds to the extracellular domains of HER2 and HER3 expressed on the surface of cells, including tumor cells, inhibiting HER2:HER3 dimerization and preventing NRG1 binding to HER3. Zenocutuzumab-zbco decreased cell proliferation and signaling through the phosphoinositide 3-kinase (PI3K)-AKT-mammalian target of rapamycin (mTOR) pathway. In addition, zenocutuzumab-zbco mediates antibody-dependent cellular cytotoxicity (ADCC). Zenocutuzumab-zbco showed antitumor activity in mouse models of NRG1 fusion-positive lung and pancreatic cancers.

Approved indications

• advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion
• advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion

Boxed warnings

• WARNING: EMBRYO-FETAL TOXICITY Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 , 8.3 )]. WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception [see Warnings and Precautions ( 5.4 ), Use on Specific Populations ( 8.1 , 8.3 )].

Common side effects

• Diarrhea
• Musculoskeletal pain
• Fatigue
• Dyspnea
• Edema
• Rash
• Infusion-related reactions
• Nausea
• Cough
• Decreased appetite
• Vomiting
• Pneumonia

Key clinical trials

• Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers (PHASE2)
• Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
• A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) (PHASE2)
• MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer. (PHASE2)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Bizengri CI brief — competitive landscape report
• Bizengri updates RSS · CI watch RSS
• Merus N.V. portfolio CI

Frequently asked questions about Bizengri

Related

• Manufacturer: Merus N.V. — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion
• Indication: Drugs for advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing