OnCo
drugsProductApproved2020🇨🇳

Margetuximab

A trastuzumab look-alike with an engineered tail that binds immune cells more tightly; approved in 2020 but rarely used after ADCs arrived.

SOPHIA (vs trastuzumab, both with chemotherapy, after ≥2 anti-HER2 lines): PFS 5.8 vs 4.9 months (HR 0.76); OS not significantly improved, with a suggestion of benefit in CD16A-158F carriers. Approved December 2020. Illustrates the ceiling of Fc engineering alone versus payload delivery.

Schematic of the modality · Fc-engineered monoclonal antibody (anti-HER2) · not a molecule; see the Monoclonal antibodies page
Modality
Fc-engineered monoclonal antibody (anti-HER2)
Mechanism
Anti-HER2 IgG1 with Fc mutations increasing FcγRIIIa (CD16A) affinity and decreasing FcγRIIb binding, enhancing ADCC.
Brand / code
Margenza
Dosing & schedule
Route
Intravenous
Schedule
15 mg/kg every 3 weeks with chemotherapy
Medicare
Part B (clinician-administered)

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.

Commercial insurance
covered with prior authorisation

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.

Not appraisedSearch NICE
Notes
No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
NHS England
Not routinely funded

Sources: NICE search: margetuximab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2020HER2+ metastatic breast cancer after ≥2 anti-HER2 regimens, with chemotherapy

Safety

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Toxicity profile
Adverse eventAny gradeGrade 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.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
7 studies0 recruiting6 Phase 22 Phase 3
Search “Margetuximab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Margetuximab
intervention: Margetuximab
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend3 papers in the last 12 monthsHow this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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