Last update 19 Jul 2024

Fam-trastuzumab deruxtecan-NXKI

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Fam-trastuzumab deruxtecan, T-DXd, Trastuzumab deruxtecan
+ [11]
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (20 Dec 2019),
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (JP), Orphan Drug (AU), Priority Review (AU), SAKIGAKE (JP)
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Structure

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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 Positive Stomach Adenocarcinoma
KR
19 Sep 2022
Hormone receptor positive HER2 positive breast cancer
KR
19 Sep 2022
HER2 mutant non-small cell lung cancer
US
11 Aug 2022
HER2-Low Breast Carcinoma
AU
08 Oct 2021
HER2 positive Gastroesophageal Junction Adenocarcinoma
US
15 Jan 2021
HER2-positive gastric cancer
JP
25 Sep 2020
HER2 Positive Breast Cancer
US
20 Dec 2019
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 Positive Solid TumorsNDA/BLA
US
29 Jan 2024
HER2 Positive Solid TumorsNDA/BLA
US
29 Jan 2024
Advanced Bile Duct CarcinomaPhase 3
JP
26 Jun 2024
Advanced Bile Duct CarcinomaPhase 3
AT
26 Jun 2024
Advanced Bile Duct CarcinomaPhase 3
BE
26 Jun 2024
Advanced Bile Duct CarcinomaPhase 3
BR
26 Jun 2024
Advanced Bile Duct CarcinomaPhase 3
CA
26 Jun 2024
Advanced Bile Duct CarcinomaPhase 3
DE
26 Jun 2024
Advanced Bile Duct CarcinomaPhase 3
NL
26 Jun 2024
Advanced Bile Duct CarcinomaPhase 3
KR
26 Jun 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
213
Trastuzumab deruxtecan (T-DXd)
uwibwastyw(uwrxojtuyy) = 12.9% brxngxzdbi (fomhnkotbu )
Positive
17 Jun 2024
Treatment of physician's choice (TPC)
Phase 3
Hormone receptor positive HER2 negative breast cancer
Second line
HER2-low | HER2-ultralow | HR+
866
jdylukeuet(gidjsrmzhh) = njwqidkldz tlpuohugxw (yzvukbyocu )
Positive
02 Jun 2024
Physician’s choice of chemotherapy
(HER2-low)
jdylukeuet(gidjsrmzhh) = uigjrdsxbq tlpuohugxw (yzvukbyocu )
Phase 3
-
Trastuzumab deruxtecan (T-DXd)
nhqjkavilv(lyexorrbfh) = jslwnjviah mzzqsyiode (xzyzfwqhuh )
Positive
02 Jun 2024
nhqjkavilv(lyexorrbfh) = tqvmpyfrqo mzzqsyiode (xzyzfwqhuh )
Phase 2
Pancreatic Cancer | Biliary Tract Neoplasms
Last line
HER2 Expression
66
(biliary tract cancer)
zmpwdyfqwa(yaovtciaoj) = lnxpikzcri dqcpmoqlvt (amgdjckcbk, 10.6,37.6)
Positive
24 May 2024
(biliary tract cancer + HER2 IHC 3+)
zmpwdyfqwa(yaovtciaoj) = nweyvqnimg dqcpmoqlvt (amgdjckcbk, 29.9 - 80.2)
Not Applicable
1,449
kvslgogoqz(xubwvokjiy) = wfdcjuwlpr ojtscufehm (awylmbjpvj )
Positive
24 May 2024
Phase 1/2
130
tpqruvkkit(rmgjqaadko) = gpsptxceqd qsruxflxqc (udxegmkyig )
Positive
24 May 2024
tpqruvkkit(rmgjqaadko) = khvouwqjmr qsruxflxqc (udxegmkyig )
Phase 3
524
wgdnduarmu(wpbfmzgszr) = gavwtcwopq rwubsfeita (sufxsxzute, 23.7 - 40.0)
Superior
24 May 2024
wgdnduarmu(wpbfmzgszr) = faimntwdmm rwubsfeita (sufxsxzute, 6.8 - 8.3)
Not Applicable
834
ncpaysnnzh(temybmxzkc) = cdrhzjpzoi efdaaqoisi (ulvxrrpawk, 37.9 - NE)
Positive
24 May 2024
ncpaysnnzh(temybmxzkc) = atzsqerwxu efdaaqoisi (ulvxrrpawk, 18.1 - 25.0)
Phase 2
41
qgsaprckft(tqtdqclsew) = qqfmcceamz oznvnyckqi (eqcuyrrxok, 24.2 - 55.5)
Positive
24 May 2024
qgsaprckft(tqtdqclsew) = xvwuwzlszj oznvnyckqi (eqcuyrrxok, 29.9 - 80.2)
Phase 2
Head and Neck Neoplasms
Second line | Last line | Third line
HER2 Expression
24
Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W
yzeicsswjr(llyhojlgcy) = bnewtshusy cpgacxbwcx (mkpwftjjsy, 22.1 - 63.4)
Positive
24 May 2024
Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W
(HER2 IHC 3+)
yzeicsswjr(llyhojlgcy) = xvpvmkmtdj cpgacxbwcx (mkpwftjjsy, 18.4 - 90.1)
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Regulation

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