BIZENGRI
GrowthmAbzenocutuzumab
BLASOLUTIONINJECTIONPriority Review
Approved
Dec 2024
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
BIZENGRI (zenocutuzumab) is 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. First approved in 2024.
Drug data last refreshed 9h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIZENGRI (zenocutuzumab-zbco) is a bispecific monoclonal antibody approved in December 2024 that simultaneously binds HER2 and HER3, blocking their dimerization and NRG1 signaling. It is designed to treat NRG1 fusion-positive tumors, particularly in lung and pancreatic cancers, by inhibiting PI3K-AKT-mTOR signaling and mediating antibody-dependent cellular cytotoxicity (ADCC). This represents a novel approach to HER2/HER3-driven cancers with a distinct mechanism from prior therapies.
Growth
Early-stage growth product with recent FDA approval; commercial team is likely expanding to establish market presence in rare oncology indications.
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…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers
Started Nov 2022
13 enrolled
NSCLC Harboring NRG1 FusionMetastatic Castration-resistant Prostate Cancer
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)
Started Jan 2015
250 enrolled
Solid Tumours Harboring NRG1 FusionNSCLC Harboring NRG1 FusionPancreatic Cancer Harboring NRG1 Fusion+1 more
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.