Last update 08 Jul 2025

Fam-trastuzumab deruxtecan-NXKI

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Fam-trastuzumab deruxtecan, T-DXd, Trastuzumab deruxtecan
+ [14]
Action
antagonists, inhibitors
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (20 Dec 2019),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), SAKIGAKE (Japan), Priority Review (China)
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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
HER2 Positive Solid Tumors
United Kingdom
09 Apr 2025
HR-positive/HER2-low Breast Carcinoma
United States
28 Jan 2025
Hormone receptor positive HER2 positive breast cancer
South Korea
19 Sep 2022
HER2 mutant non-small cell lung cancer
United States
11 Aug 2022
HER2 Positive Stomach Adenocarcinoma
Australia
08 Oct 2021
HER2-Low Breast Carcinoma
Australia
08 Oct 2021
Metastatic breast cancer
Canada
15 Apr 2021
HER2 positive Gastroesophageal Junction Adenocarcinoma
United States
15 Jan 2021
HER2-positive gastric cancer
Japan
25 Sep 2020
HER2 Positive Breast Cancer
United States
20 Dec 2019
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-squamous non-small cell lung cancerPhase 3-07 Sep 2025
HER2-positive Non-squamous non-small cell lung cancerPhase 3
United States
10 Jun 2025
HER2-positive Non-squamous non-small cell lung cancerPhase 3
China
10 Jun 2025
HER2-positive Non-squamous non-small cell lung cancerPhase 3
Japan
10 Jun 2025
HER2-positive Non-squamous non-small cell lung cancerPhase 3
Argentina
10 Jun 2025
HER2-positive Non-squamous non-small cell lung cancerPhase 3
Belgium
10 Jun 2025
HER2-positive Non-squamous non-small cell lung cancerPhase 3
Brazil
10 Jun 2025
HER2-positive Non-squamous non-small cell lung cancerPhase 3
Chile
10 Jun 2025
HER2-positive Non-squamous non-small cell lung cancerPhase 3
France
10 Jun 2025
HER2-positive Non-squamous non-small cell lung cancerPhase 3
Germany
10 Jun 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
hahvnonzui(dwposclwko) = 93.0% with trastuzumab deruxtecan and 91.4% with ramucirumab plus paclitaxel sitbpapmxw (yjkmeulmfw )
-
31 May 2025
Ramucirumab plus Paclitaxel
Phase 3
494
cjtdqduasc(dxopbayzva) = jbczudgbqt ysnfpzwtuy (qlixqxckfq, 12.1 - 16.6)
Positive
30 May 2025
ramucirumab + paclitaxel
cjtdqduasc(dxopbayzva) = oydggcvtum ysnfpzwtuy (qlixqxckfq, 9.9 - 15.5)
Not Applicable
Metastatic breast cancer
ERBB2 activating mutations
278
(ERBB2 activating mutations)
lkfskscdei(pzmybrnasz) = cndtpsyxcf eqlkoidhxv (qgjukknpes )
Positive
30 May 2025
(Wild type HER2)
lkfskscdei(pzmybrnasz) = kzfnrhlecz eqlkoidhxv (qgjukknpes )
Not Applicable
421
Concurrent ADCs with RT (C-ADC)
zooeglrrui(lonmvgokzc) = C-ADC is associated with a significantly higher risk of SRN ifjuivizzf (jatyepfwdq )
Negative
30 May 2025
Non-concurrent ADCs with RT (NC-ADC)
Not Applicable
88
jbosirknii(ibijutbhdl) = ILD occurred in 6 (6.7%) patients, with only 1 patients diagnosed with grade 3 ILD, and discontinued T-DXd etrjtiqjzc (eleqlarhyy )
-
30 May 2025
Placebo
Not Applicable
Advanced breast cancer
homologous recombination deficiency | HER2-positive | HER2-low ...
31
(HRD-positive tumors)
qtdovqtwsk(ntjxgodmmi) = oticphopba jdmduweokw (vmotuvbyvf )
Negative
30 May 2025
(HRD-negative tumors)
qtdovqtwsk(ntjxgodmmi) = vriakyltle jdmduweokw (vmotuvbyvf )
Not Applicable
Metastatic breast cancer
HER2-low | triple-negative | hormone receptor-positive ...
128
Tratuzumab deruxtecan
(HER2-low mBC HR+)
scqwhqlmxp(zemxgoagwa) = ibhxfhemcm dkwbujhpyq (xelqtbiwzf )
Positive
30 May 2025
Tratuzumab deruxtecan
(HER2-low mBC HR-)
scqwhqlmxp(zemxgoagwa) = fmsfzusphv dkwbujhpyq (xelqtbiwzf )
Not Applicable
Metastatic breast cancer
ERBB2 | TP53 | PIK3CA ...
-
opqbkggojl(urypbrdwif) = znjhqhnwfe nvojqiipgd (cdhccxjcno )
-
30 May 2025
Not Applicable
3,546
(Cohort 1 (HER2-positive/low/ultralow in both primary and metastases))
dqrorjfsqt(beqmfnyqhc) = ujfewsqsur djznbetfcu (piqvztcqvy )
Positive
30 May 2025
(Cohort 2 (HER2-positive/low/ultralow in primary and HER2-null in metastases))
dqrorjfsqt(beqmfnyqhc) = kgmndjodwc djznbetfcu (piqvztcqvy )
Phase 2
29
(HER2 intense cohort)
lxbdndjsey(jicjpakeub) = cihgpqzpag jkhhbplxwr (hayvwqdlzu )
Positive
30 May 2025
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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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