Margetuximab · Margenza, MGAH-22

What is Margetuximab?

Margetuximab is an antibody that binds the extracellular domain of the HER2 protein on tumor cells, inhibiting proliferation and reducing HER2 shedding. Its modified Fc region increases engagement of activating Fc receptor CD16A and reduces binding to CD32B, enhancing antibody-dependent cellular cytotoxicity. It is studied in HER2-positive metastatic breast cancer in combination with chemotherapy.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Margenza, MGAH-22

Drug type

Monoclonal antibody

Targets

HER2 (ERBB2) extracellular domain (ERBB2), FCGR3A (CD16A) (FCGR3A) (secondary target), FCGR2B (CD32B) (FCGR2B) (secondary target)

Mechanism

Antagonist of HER2 (ERBB2) extracellular domain (ERBB2)

Pathways

antibody-dependent cellular cytotoxicity, NK cell activation, inhibition of tumor cell proliferation, reduction of HER2 extracellular domain shedding

Therapy area

Oncology

Developer

Tersera Therapeutics Llc

In trials of

ZLAB

FDA status

Approved as Margenza (December 16, 2020), BLA761150 · FDA label

UNII

K911R84KEW

✅ FDA-approved uses

• HER2-positive breast cancer

From the indications section of the FDA label (version of Feb 11, 2025). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

HER2 Positive Metastatic Breast Cancer

Other drugs acting on ERBB2

Sources

• FDA Purple Book
• FDA label (DailyMed)
• FDA label Margenza (2025-02-11), indications
• ClinicalTrials.gov NCT04398108

Updated Nov 1, 2026.