Drug · Monoclonal Antibody
Margetuximab
CI-DRUG-00000369Explore in graph →NCIt C91733 CHEMBL2364649 CIViC Approved
Regulatory
Approvals (2)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
openfdaProvenance
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-24
- Retrieved
- Sep 28, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260928-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2023-05-25 (see label) | approved | May 25, 2023 | openfda |
| US FDA | HER2-Positive Breast Carcinoma | 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 (2.1) and Clinical Studies (14.1) ]. 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. ( 1 , 2.1 , 14.1 ) | approved | Dec 16, 2020 | openfda |
Data updated 2 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 1 | 0 | 2 | 9 | 2 | US | Dec 16, 2020 | 2010-07 |
| Malignant Breast Neoplasm | Approved | Phase 2 | 1 | 0 | 0 | 4 | 1 | US | Dec 16, 2020 | 2010-07 |
| Malignant Gastric Neoplasm | Phase3 | Phase 3 | 0 | 0 | 1 | 3 | 0 | — | — | 2010-07 |
| Malignant Esophageal Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 1 | 0 |
Curated evidence
Clinical evidence (1)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 33480963
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| ERBB2 Amplification1 | ||||||||
| Margetuximab | Malignant Breast Neoplasm | |||||||
Clinical trials
Trials with this intervention (10)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT04425018 | MARGetuximab Or Trastuzumab (MARGOT)(MARGOT) | active not recruiting | Phase 2 | 174 | Dana-Farber Cancer InstituteOTHER | 1 | Nov 18, 2025 | clinicaltrials |
| NCT04082364 | Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer(MAHOGANY) |