BIZENGRI
BIZENGRI (zenocutuzumab-zbco) is a bispecific antibody indicated for the treatment of adult patients with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma. It is specifically indicated for patients whose tumors harbor a neuregulin 1 (NRG1) gene fusion and who have experienced disease progression on or after prior systemic therapy. This drug received accelerated approval based on overall response rate and duration of response, and continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
How BIZENGRI Works
Zenocutuzumab-zbco is a bispecific antibody that binds to the extracellular domains of HER2 and HER3 on the surface of tumor cells. This binding inhibits HER2:HER3 dimerization and prevents NRG1 from binding to HER3, which decreases cell proliferation and signaling through the PI3K-AKT-mTOR pathway. Additionally, the drug mediates antibody-dependent cellular cytotoxicity (ADCC) to facilitate the destruction of tumor cells.
Details
- Status
- Prescription
- First Approved
- 2024-12-04
- Routes
- SOLUTION
- Dosage Forms
- INJECTION
BIZENGRI Approval History
What BIZENGRI Treats
2 indicationsBIZENGRI is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
- Pancreatic Adenocarcinoma
BIZENGRI Boxed 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 effecti...
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 )].
BIZENGRI Target & Pathway
ProTarget
A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.
Pathway Context
HER2 forms dimers with other HER family members to activate growth signaling
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
BIZENGRI Competitors
Pro10 other drugs also target HER2. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (HER2). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BIZENGRI FDA Label Details
ProIndications & Usage
FDA Label (PDF)BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the 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.* Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* *This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval fo...
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 TOXI...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.