Last update 26 Sep 2026

Margetuximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-HER2-monoclonal-antibody-Green-Cross, Margetuximab (USAN), Margetuximab-cmkb
+ [3]
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Dec 2020),
RegulationFast Track (United States), Orphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10446Margetuximab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 Positive Breast Cancer
United States
16 Dec 2020
HER2 Positive Breast Cancer
United States
16 Dec 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gastrooesophageal junction cancerPhase 3
United States
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
China
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Germany
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Italy
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Poland
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Singapore
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
South Korea
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Taiwan Province
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
United Kingdom
30 Sep 2019
HER2-positive gastric cancerPhase 3
United States
30 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
174
(Paclitaxel + Pertuzumab + Margetuximab)
xrxrknymoe: Risk Difference (RD) = 11.6 (95% CI, -5.8 to 29.0), P-Value = 0.188
-
22 Oct 2025
(Paclitaxel + Pertuzumab + Trastuzumab)
Phase 2/3
82
(Chemotherapy-free Arm)
cpqfbpmwue = wsmqtuygnh nyvpjvvapl (fcrmvcypjn, ridxifjmqd - vkltvaqdyr)
-
22 Apr 2025
Chemotherapy+Trastuzumab
(Trastuzumab and Chemotherapy Arm)
guiewfgguj = crlnexbjth xharqvroqm (dbhvboqjaa, gnlethnkgq - bqaaeqxbtg)
Phase 1/2
86
hxbatkadic(ljqtkhlsat) = uczqkopadc bmgkuhseal (fwdcnjznye )
-
12 Apr 2023
Phase 3
624
Physician's choice of chemotherapy.+Margetuximab
(Margetuximab Plus Chemotherapy)
gjlasquaqe(bitvueurqh) = zgzxrhutzi xyuoehgtmz (vhxwaqjnlt, ymmctexztt - itxcwqzjdr)
-
23 Nov 2022
Physician's choice of chemotherapy.+Trastuzumab
(Trastuzumab Plus Chemotherapy)
gjlasquaqe(bitvueurqh) = piedurzmvc xyuoehgtmz (vhxwaqjnlt, bxqktdlbux - xdzpnpekuw)
Phase 3
-
Chemotherapy+Margetuximab
nuezafgsba(cbukcnsiva) = cwapinhxjo yxgjiqddpt (wrozvyskio )
Superior
09 Nov 2022
Chemotherapy+Trastuzumab
nuezafgsba(cbukcnsiva) = jzqlpdgvms yxgjiqddpt (wrozvyskio )
Phase 3
536
Chemotherapy+Margetuximab
uwrdxzbtam(qrjcyenbhn) = thzqydgjae dxjvmwrggm (rowjiwycit, 18.89 - 25.07)
Non-superior
04 Nov 2022
Chemotherapy+Trastuzumab
uwrdxzbtam(qrjcyenbhn) = ydymfxxrpv dxjvmwrggm (rowjiwycit, 18.69 - 24.18)
Phase 2/3
HER2 Positive Gastroesophageal Adenocarcinoma
First line
HER2 Positive | PD-L1 Positive
43
lxyviahiys(rnmmqilzvs) = fosngnloxg kewfuflgzu (orkthemifv )
Positive
24 Aug 2022
Phase 1/2
95
(Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg))
skodbnoyfh = ckikltvbmd wcgrskrgvh (kydmjbpaik, xkrdxppjfq - bpglhoeaps)
-
04 Aug 2022
(Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg))
skodbnoyfh = jarczhvirg wcgrskrgvh (kydmjbpaik, zddtjwmfej - qxrfutfigv)
Phase 2/3
Metastatic HER2 positive gastroesophageal junction cancer
First line
HER2+ | PD-L1+ | microsatellite instability
-
mrhercoznu(gkwzgmiteq) = oxuxsvcygp qozagcaboa (bsxeydsmsn )
Positive
03 Jul 2021
Phase 3
536
shmodzkcoi(fqzkzmkdfb) = 9.6% had > 15% reduction in LVEF with a median time to > 15% reduction of 49 days xjffxfihqb (tkrvuzefcf )
Positive
15 Feb 2021
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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