MARGENZA is a HER2/neu receptor antagonist indicated for use in combination with chemotherapy to treat adult patients with metastatic HER2-positive breast cancer. It is intended for patients who have already received two or more prior anti-HER2 regimens. At least one of these previous treatments must have been administered for metastatic disease.
How MARGENZA Works
Margetuximab-cmkb binds to the extracellular domain of the HER2 protein, which inhibits tumor cell proliferation and reduces the shedding of the HER2 extracellular domain. The drug features a modified Fc region that increases binding to activating Fc receptors and decreases binding to inhibitory Fc receptors. These changes lead to enhanced antibody-dependent cellular cytotoxicity (ADCC) and natural killer (NK) cell activation against the tumor.
Details
- Status
- Prescription
- First Approved
- 2020-12-16
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
MARGENZA Approval History
What MARGENZA Treats
1 indicationsMARGENZA is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
MARGENZA Boxed Warning
LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function. ( 2.2 , 5.1 , 6.1 ) Embryo-Fetal Toxicity: Exp...
WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function. ( 2.2 , 5.1 , 6.1 ) Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception. ( 5.2 , 8.1 , 8.3 ) Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Adverse Reactions (6.1) ]. Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions (5.2) , Use in Specific Populations (8.1 , 8.3) ].
MARGENZA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in MARGENZA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MARGENZA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to MARGENZA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
MARGENZA FDA Label Details
Indications & Usage
FDA Label (PDF)MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration and Clinical Studies ]. MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Eva...
Track MARGENZA with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.