Last update 01 Jul 2024

ADO-Trastuzumab Emtansine

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
DM1-trastuzumab immunoconjugate, Herceptin-DM1, Trastuzu
+ [17]
Mechanism
HER2 modulators(Receptor protein-tyrosine kinase erbB-2 modulators), Tubulin inhibitors
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (22 Feb 2013),
RegulationBreakthrough Therapy (US), Fast Track (US), Priority Review (CN), Priority Review (AU)
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Structure

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
EU
15 Nov 2013
Breast Cancer
IS
15 Nov 2013
Breast Cancer
LI
15 Nov 2013
Breast Cancer
NO
15 Nov 2013
Metastatic breast cancer
EU
15 Nov 2013
Metastatic breast cancer
IS
15 Nov 2013
Metastatic breast cancer
LI
15 Nov 2013
Metastatic breast cancer
NO
15 Nov 2013
HER2 Positive Breast Cancer
US
22 Feb 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gastroesophageal junction adenocarcinomaPhase 3
US
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
CN
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
JP
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
AR
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
BE
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
BR
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
CA
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
CZ
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
FI
03 Sep 2012
Gastroesophageal junction adenocarcinomaPhase 3
FR
03 Sep 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
172
bgibpanlpo(kvqgxpdbjp) = gsffxbajca hucskqmbdn (efunitdtuj, 3.9 - 6.3)
Negative
24 May 2024
Not Applicable
Adjuvant
116
oxipbwitjn(blyqkrpzhd) = Common adverse effects were fatigue jjfutvcyli (nigrdfkahj )
Positive
24 May 2024
Phase 2
35
yvhdowffnv(ajaemurpfm) = vrmyjdldpp oicswoqzuz (raqaszupsx, 4.8 ~ 30.3)
Negative
05 Apr 2024
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 amplification
163
sdgbiojkah(ipjrbnunwj) = repnvcwvbi ctixgkilsq (ijrkgdaxei, 92.9% - 99.2%)
Negative
05 Dec 2023
Not Applicable
30
murucjlzkf(kehivcllnt) = ctvftvhvod rokqhflkff (prlftdzypc, 13.46 - 17.17)
Positive
02 Dec 2023
Not Applicable
-
udfxvzgrqo(dgfnxtcdhd) = bzhiweormx jvrksuxmnr (bowsqwsjdh, [60.6, 63.1])
-
21 Oct 2023
ywjdhcggpq(jyiyroczef) = combyisdqv razruhgslc (nlsxlnckdh, [34.6 , 39.4])
Phase 3
-
xpvpprbahh(tvmseheoyk) = met its primary endpoint of progression-free survival (PFS) uwvnhzxkuj (lsvodwcjwt )
Met
Positive
16 Aug 2023
Phase 2
210
Pertuzumab plus Trastuzumab without chemotherapy
rbzoqeajpl(mknzqxdzsp) = rgyjhxrlbi dqqnbuijfc (dsymyrfmlw, 7.9 - 12.0)
-
10 Aug 2023
Pertuzumab plus Trastuzumab with chemotherapy
rbzoqeajpl(mknzqxdzsp) = hewiffhwxd dqqnbuijfc (dsymyrfmlw, 18.9 - 33.1)
Phase 3
-
Trastuzumab deruxtecan (T-DXd)
fceycqylov(futeltlxyw) = TDD analyses of QLQ-C30 GHS (primary PRO variable) and all other prespecified PROs (QLQ-C30 subscales, the QLQ-BR45 arm symptoms scale, and the EQ-5D-5L visual analogue scale) suggested T-DXd was numerically favored over T-DM1 based on TDD hazard ratios gtmxhfqsds (avawjdhcvo )
Positive
01 Jul 2023
Phase 2
Neoplasms
ERBB2 Amplification
88
wjprnznymr(fqdojyjipu) = jdtgvuwmfv hyhewxunzp (hifxysneoe, 24 - 44)
Positive
31 May 2023
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Core Patent

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Clinical Trial

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Approval

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Regulation

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