Last update 08 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),
RegulationFast Track (United States), Priority Review (Australia), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC35H48ClN3O10S
InChIKeyANZJBCHSOXCCRQ-FKUXLPTCSA-N
CAS Registry139504-50-0
View All Structures (2)
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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
Liechtenstein
15 Nov 2013
Early Stage Breast Carcinoma
Iceland
15 Nov 2013
Early Stage Breast Carcinoma
European Union
15 Nov 2013
Early Stage Breast Carcinoma
Norway
15 Nov 2013
Metastatic breast cancer
Norway
15 Nov 2013
Metastatic breast cancer
European Union
15 Nov 2013
Metastatic breast cancer
Liechtenstein
15 Nov 2013
Metastatic breast cancer
Iceland
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
HER2 Positive Breast CancerPhase 3
Singapore
01 Feb 2009
HER2 Positive Breast CancerPhase 3
Hong Kong
01 Feb 2009
HER2 Positive Breast CancerPhase 3
New Zealand
01 Feb 2009
HER2 Positive Breast CancerPhase 3
India
01 Feb 2009
HER2 Positive Breast CancerPhase 3
Philippines
01 Feb 2009
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
United States
-
HER2 Positive Breast CancerPreclinical
Philippines
01 Feb 2009
HER2 Positive Breast CancerPreclinical
New Zealand
01 Feb 2009
HER2 Positive Breast CancerPreclinical
India
01 Feb 2009
HER2 Positive Breast CancerPreclinical
Singapore
01 Feb 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
(mwjnlczwgs): 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)
(ohpageoyxu) = gtethdxnyv ziegnwhmgc (yrkxxnanbf )
Positive
07 Dec 2024
(Residual Cancer Burden (RCB) Class 2)
wbfnkxmiyu(nlxebqflao) = jxzamztvne tmhrafjpfi (hymrohomgv )
Phase 1
20
wotrjonbpl(irwbshkgfx) = uxozwpfyhe qtijekkjru (vufffkzzyi, azundijcsm - mfdicvorur)
-
02 Dec 2024
Phase 3
421
Trastuzumab deruxtecan (T-DXd)
(HER2 CN high)
(dakhlvzhix) = ncosqbzxve jqfawdzqyo (emwxvpoiwt, 76.1 - 94.3)
Positive
26 Nov 2024
(HER2 CN low)
(dakhlvzhix) = kexgmipllv jqfawdzqyo (emwxvpoiwt, 69.1 - 90.3)
Phase 2
55
(T-DM1 With Palbociclib)
pfjjqvstdm(dlayifiudh) = mzdajonmkv bgnvjjxjvx (beyhzqzaaq, nrtccyeqiw - ubcpnkqdju)
-
24 Jul 2024
(Single Agent T-DM1)
pfjjqvstdm(dlayifiudh) = olhtsuzwpp bgnvjjxjvx (beyhzqzaaq, atmcktowzj - qcdicgxzzm)
Phase 3
309
mjlvwhqndp(ngvdnkkvxv) = pslsksxqpd ktnplqgmup (zevooefuax )
Positive
09 Jul 2024
mjlvwhqndp(ngvdnkkvxv) = rotebrjuos ktnplqgmup (zevooefuax )
Phase 2
20
H2NVAC + T-DM1
(pkqkbnkhcc) = orumguuvuk rwpsgdjfgg (ebopzeeclb )
Positive
24 May 2024
Phase 3
148
(daxkxvopep) = potmhlacwn favrtlajpx (ncghutcjsg, 0.310 - 1.808)
Negative
24 May 2024
Not Applicable
172
(sdjzdwtusg) = hoesqcchtg jjphargams (jjgloatlhf, 3.9 - 6.3)
Negative
24 May 2024
Not Applicable
Adjuvant
116
(egxjalvfmo) = Common adverse effects were fatigue ghzhfgqbrr (dfjhijbocd )
Positive
24 May 2024
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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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