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MARGENZA (MARGETUXIMAB-CMKB)
MARGENZA (generic name: MARGETUXIMAB-CMKB) is a HER2/neu Receptor Antagonist [EPC] drug developed by MACROGENICS INC. It is currently FDA-approved for Metastatic human epidermal growth factor 2 positive carcinoma of breast.
At a glance
| Generic name | MARGETUXIMAB-CMKB |
|---|---|
| Sponsor | MACROGENICS INC |
| Drug class | HER2/neu Receptor Antagonist [EPC] |
| Target | Low affinity immunoglobulin gamma Fc region receptor III-A, Receptor tyrosine-protein kinase erbB-2 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Metastatic human epidermal growth factor 2 positive carcinoma of breast
Boxed warnings
- 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) ].
Common side effects
- Fatigue/Asthenia
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Pyrexia
- Headache
- Alopecia
- Abdominal pain
- Peripheral neuropathy
- Cough
- Decreased appetite
Serious adverse events
- Febrile neutropenia
- Neutropenia/Neutrophil count decrease
- Infusion-related reactions
- Viral pneumonia
- Left ventricular dysfunction
- Aspiration pneumonia
- Peripheral neuropathy
- Diarrhea
- Dyspnea
- Vomiting
Key clinical trials
- MARGetuximab Or Trastuzumab (MARGOT): A Phase II Study Comparing Neoadjuvant Paclitaxel/Margetuximab/Pertuzumab to Paclitaxel/Trastuzumab/Pertuzumab in Patients With Stage II-III HER2-positive Breast (Phase 2)
- A Phase 2/3 Trial to Evaluate Margetuximab in Combination With INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients With Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive G (Phase 2)
- A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therap (Phase 3)
- A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein Binding PD-1 and LAG-3 in Patients With Unresectable or Metastatic Neoplasms (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- MARGENZA CI brief — competitive landscape report
- MARGENZA updates RSS · CI watch RSS
- MACROGENICS INC portfolio CI
Frequently asked questions about MARGENZA
What is MARGENZA?
MARGENZA (MARGETUXIMAB-CMKB) is a HER2/neu Receptor Antagonist [EPC] drug developed by MACROGENICS INC, indicated for Metastatic human epidermal growth factor 2 positive carcinoma of breast.
What is MARGENZA used for?
MARGENZA is indicated for Metastatic human epidermal growth factor 2 positive carcinoma of breast.
Who makes MARGENZA?
MARGENZA is developed and marketed by MACROGENICS INC (see full MACROGENICS INC pipeline at /company/macrogenics-inc).
What is the generic name of MARGENZA?
MARGETUXIMAB-CMKB is the generic (nonproprietary) name of MARGENZA.
What drug class is MARGENZA in?
MARGENZA belongs to the HER2/neu Receptor Antagonist [EPC] class. See all HER2/neu Receptor Antagonist [EPC] drugs at /class/her2-neu-receptor-antagonist-epc.
What development phase is MARGENZA in?
MARGENZA is FDA-approved (marketed).
What are the side effects of MARGENZA?
Common side effects of MARGENZA include Fatigue/Asthenia, Nausea, Diarrhea, Vomiting, Constipation, Pyrexia. Serious adverse events: Febrile neutropenia, Neutropenia/Neutrophil count decrease, Infusion-related reactions, Viral pneumonia.
What does MARGENZA target?
MARGENZA targets Low affinity immunoglobulin gamma Fc region receptor III-A, Receptor tyrosine-protein kinase erbB-2 and is a HER2/neu Receptor Antagonist [EPC].
Related
- Drug class: All HER2/neu Receptor Antagonist [EPC] drugs
- Target: All drugs targeting Low affinity immunoglobulin gamma Fc region receptor III-A, Receptor tyrosine-protein kinase erbB-2
- Manufacturer: MACROGENICS INC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic human epidermal growth factor 2 positive carcinoma of breast
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing