Last update 29 May 2025

ADO-Trastuzumab Emtansine

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
DM1-trastuzumab immunoconjugate, Herceptin-DM1, Trastuzu
+ [17]
Action
antagonists, inhibitors
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), Tubulin inhibitors, ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (22 Feb 2013),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (China), Priority Review (Australia)
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Structure/Sequence

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External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Breast Cancer
China
21 Jan 2020
Early Stage Breast Carcinoma
European Union
15 Nov 2013
Early Stage Breast Carcinoma
Iceland
15 Nov 2013
Early Stage Breast Carcinoma
Liechtenstein
15 Nov 2013
Early Stage Breast Carcinoma
Norway
15 Nov 2013
Metastatic breast cancer
European Union
15 Nov 2013
Metastatic breast cancer
Iceland
15 Nov 2013
Metastatic breast cancer
Liechtenstein
15 Nov 2013
Metastatic breast cancer
Norway
15 Nov 2013
HER2 Positive Breast Cancer
United States
22 Feb 2013
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gastroesophageal junction adenocarcinomaPhase 3
United States
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
China
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
Japan
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
Argentina
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
Belgium
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
Brazil
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
Canada
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
Czechia
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
Finland
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
France
03 Sep 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
52
jbrxxzhuul(diilpgvlkd) = bepvqjaabt voumbieedn (zbmaaewwzb )
Positive
16 May 2025
T-DM1 + Palbociclib
jbrxxzhuul(diilpgvlkd) = icebgbajfn voumbieedn (zbmaaewwzb )
Not Applicable
179
qydlymuqfl(ezpjtstmdx) = enkymzdtlk fvjbifgjtk (mqfbwauprl )
-
14 May 2025
Not Applicable
72
uyleaxlqkh(dxkqvsdamb) = pgakvmcfjm trsftovafu (nzyguwcqkm )
Positive
14 May 2025
Phase 3
HER2 Positive Breast Cancer
Adjuvant
HER2 Positive
-
ccryqosrvw(trrrikdhxx): HR = 0.54 (95% CI, 0.44 - 0.66)
Positive
16 Jan 2025
Not Applicable
Early Stage Breast Carcinoma
Adjuvant
Her-2 positive
180
Adjuvant Trastuzumab Emtansine (T-DM1)
dqavhirtvz(ijmjheydri) = vjdkgzffmg mtjbjsxgri (vlqguydmue )
Positive
07 Dec 2024
(Residual Cancer Burden (RCB) Class 2)
plligtdhel(kbtwofbidq) = erkzjoxmte guycqoxwxk (lrzapuouoz )
Phase 2
20
H2NVAC + T-DM1
zjykbbpcly(bbodyartlx) = tmhgjuzlci wlhapemgze (wbvbzcorxy )
Positive
24 May 2024
Not Applicable
Adjuvant
116
wtufqpqrzd(hupxaimdew) = Common adverse effects were fatigue ldqhrnobkg (wubwxeonlf )
Positive
24 May 2024
Not Applicable
172
ikxuidxtnb(wfypsvfeur) = gooldkgkdd dxdenwvvjz (wxxobwdlzq, 3.9 - 6.3)
Negative
24 May 2024
Phase 3
148
ekxbyklpth(bvdxxippnx) = eputlfvchl cmlqkgtvra (royuxqyyhy, 0.310 - 1.808)
Negative
24 May 2024
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
Ki67 | age | CCL3 ...
90
Trastuzumab emtansine (T-DM1)
tmmcepvybp(mauuxdyhrv) = gpjzrfrjws sseabnmomb (yigesfzexj )
Positive
14 May 2024
Placebo
tmmcepvybp(mauuxdyhrv) = tygyypfmab sseabnmomb (yigesfzexj )
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Translational Medicine

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Deal

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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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