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A trastuzumab look-alike with an engineered tail that binds immune cells more tightly; approved in 2020 but rarely used after ADCs arrived.
Margetuximab is an anti-HER2 IgG1 antibody whose Fc region is engineered to bind the activating receptor FcγRIIIa (CD16A) more tightly and the inhibitory FcγRIIb less, enhancing antibody-dependent cellular cytotoxicity; its HER2-binding arm is otherwise trastuzumab-like. It is approved for HER2-positive metastatic breast cancer after two or more anti-HER2 regimens, given with chemotherapy at 15 mg/kg every 3 weeks. SOPHIA (versus trastuzumab, both with chemotherapy) showed PFS of 5.8 versus 4.9 months (HR 0.76); overall survival was not significantly improved, with a suggestion of benefit in CD16A-158F carriers. It was approved in December 2020 but is rarely used since antibody-drug conjugates arrived. It illustrates the ceiling of Fc engineering alone versus payload delivery. For a newcomer, it is a trastuzumab look-alike with a sharper immune tail that did not change practice.
Anti-HER2 IgG1 with Fc mutations increasing FcγRIIIa (CD16A) affinity and decreasing FcγRIIb binding, enhancing ADCC. Connects to HER2.
1.Margetuximab binds HER2.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE search: margetuximab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
| Region | Year | Indication |
|---|---|---|
| US | 2020 | HER2+ metastatic breast cancer after ≥2 anti-HER2 regimens, with chemotherapy |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Infusion-related reactions | 13% | - |
| Left ventricular dysfunction | 2% | - |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Margetuximab" OR ABSTRACT:"Margetuximab" OR TITLE:"Margenza" OR ABSTRACT:"Margenza") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Margetuximab, not a curated reading list.
Shares Fc engineering / effector function, ADCC (antibody-dependent cellular cytotoxicity), Monoclonal antibodies.
Shares Fc engineering / effector function, ADCC (antibody-dependent cellular cytotoxicity), NK-cell recognition: missing self & stress ligands, Monoclonal antibodies.
Shares Fc engineering / effector function, ADCC (antibody-dependent cellular cytotoxicity), Monoclonal antibodies.
Shares NK-cell recognition: missing self & stress ligands, HER2-positive breast cancer.
Shares HER2 IHC 3+ (HER2-positive by immunohistochemistry), HER2, HER2-positive breast cancer.
Shares MARGetuximab Or Trastuzumab (MARGOT), HER2, HER2-positive breast cancer, Monoclonal antibodies.
Shares Fc engineering / effector function, Monoclonal antibodies.
Shares Fc engineering / effector function, ADCC (antibody-dependent cellular cytotoxicity), Monoclonal antibodies.