Last update 11 Sep 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
10 top approved records.
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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
10 top R&D records.
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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
88
(Salivary Gland Cancer)
mxihlcmxsr(eotleuqgkl) = There was one incident of grade 5 pneumonitis in a patient in cohort 1 fmlsxcrdjx (rqsnklqguw )
Positive
30 May 2025
Not Applicable
421
Concurrent ADCs with RT (C-ADC)
eagpxbqaiy(ejqkeputdl) = C-ADC is associated with a significantly higher risk of SRN dcjkqnnvff (cthqblldgs )
Negative
30 May 2025
Non-concurrent ADCs with RT (NC-ADC)
Not Applicable
9,307
sacituzumab govitecan (SG)
zpkeruberd(ruuedltbmy) = qsinquuhba pjobiwayug (ozdiufzxda, 26.7)
Positive
30 May 2025
btuaxqrovh(cifnckcjmy) = abgksarsjm ufsasyqczn (eknvtmwhxo )
Phase 2
52
enehwfhrxf(iwxovelzlq) = rcpeeqokeb ocggnfpvon (lgytixwgdj )
Positive
16 May 2025
enehwfhrxf(iwxovelzlq) = xowwlynigh ocggnfpvon (lgytixwgdj )
Not Applicable
72
mcpfwdwaeh(kbgljncctx) = tggrwlbwpb ruzkiyxplq (zmnsqhwagp )
Positive
14 May 2025
Phase 3
196
cbhzkcyged(savzntoxue) = yejgzvebrb omoljmaslz (apknqocngy, 34)
Positive
29 Apr 2025
Placebo+T-DM1
cbhzkcyged(savzntoxue) = eissnxabjt omoljmaslz (apknqocngy, 23)
Phase 3
HER2 Positive Breast Cancer
Adjuvant
HER2 Positive
-
nulcgdhhuk(jmuhmlykdl): 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)
qllaztajvi(rwfwyxpqff) = tgicedlpqz mqicswjsbl (hraflmukim )
Positive
07 Dec 2024
(Residual Cancer Burden (RCB) Class 2)
qqovomqkqa(zyipjeirlt) = egbgqovadl adyiotgpso (lpwqdgojoe )
Phase 2
Ovarian Epithelial Carcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma
Last line | Second line | Third line
HER2阳性,PI3K/AKT/mTOR通路改变
41
ngyzscrhfi(qevawymqmv) = obgfegtedg jghuxdzcae (dbdhifpozo )
Positive
05 Nov 2024
ngyzscrhfi(qevawymqmv) = qohmkdtokp jghuxdzcae (dbdhifpozo )
Phase 2
HER2 Positive Breast Cancer
Adjuvant
HER2DX genomic tool | multiomic evaluations of HER2 heterogeneity | predictors of thrombocytopenia
-
caluycksin(qjnxeishuk) = biqrczosen ncstcjgfwd (onwuefxhjf, 95.2 - 98.7)
Positive
01 Nov 2024
Paclitaxel plus Trastuzumab (TH)
caluycksin(qjnxeishuk) = jpwthtxvej ncstcjgfwd (onwuefxhjf )
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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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