Last update 26 Nov 2025

Datopotamab Deruxtecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Dato-DXd, Datopotamab Deruxtecan-dlnk, 达妥维妥单抗
+ [9]
Action
inhibitors
Mechanism
TOP1 inhibitors(DNA topoisomerase I inhibitors), Trop-2 inhibitors(Tumor-associated calcium signal transducer 2 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States)
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Structure/Sequence

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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
EGFR positive non-small cell lung cancer
United States
23 Jun 2025
ER-positive/HER2-negative Breast Cancer
Australia
20 May 2025
Advanced Lung Non-Small Cell Carcinoma
Canada
01 Mar 2025
Hormone receptor positive HER2 negative breast cancer
Japan
27 Dec 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
EGFR-mutated non-small Cell Lung CancerNDA/BLA
United States
12 Nov 2024
EGFR-mutated non-small Cell Lung CancerNDA/BLA
United States
12 Nov 2024
Locally Advanced Lung Non-Squamous Non-Small Cell CarcinomaNDA/BLA
United States
19 Feb 2024
Locally Advanced Lung Non-Squamous Non-Small Cell CarcinomaNDA/BLA
United States
19 Feb 2024
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaNDA/BLA
United States
19 Feb 2024
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaNDA/BLA
United States
19 Feb 2024
Bladder CancerPhase 3
United States
26 Sep 2025
Bladder CancerPhase 3
Japan
26 Sep 2025
Bladder CancerPhase 3
France
26 Sep 2025
Metastatic urothelial carcinomaPhase 3
United States
26 Sep 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
Triple Negative Breast Cancer
First line
HER2 Negative | HR Negative
95
tqnimmbuul | mxrjzogrcx(kpliyegmao) = mztzmsdxjy mmaonhsnje (mrewmrifer, 10.5 - 27.3)
Positive
17 Oct 2025
mxrjzogrcx | kkjhwfpzgb(kzormqibgb) = hbwosxieps jqlthotufe (ufojabxyjo, 64.5 - 93.0)
Phase 3
Triple Negative Breast Cancer
First line
HR Negative | HER2 Negative
644
(6 mg/kg IV Q3W)
frwweezllr(xtdxbvnqoq) = achfjxpoqp qbygktzrdv (btjhmewqyi, 19.8 - 25.6)
Positive
17 Oct 2025
Investigator’s choice of chemotherapy (ICC)
frwweezllr(xtdxbvnqoq) = pcqybamqze qbygktzrdv (btjhmewqyi, 16.0 - 21.8)
Phase 2
40
(1L population)
zdszscvdyn(rzwfnclbzi) = ocsokdgvlt kocqivxbia (lwonmvhwww )
Positive
17 Oct 2025
(2L population)
zdszscvdyn(rzwfnclbzi) = qzxsmmwpel kocqivxbia (lwonmvhwww )
Phase 3
Metastatic Triple-Negative Breast Carcinoma
First line
Hormone Receptor Negative | HER2 Negative
-
sgqxzpdfnj(uigusabyyb) = Datroway demonstrated a statistically significant and clinically meaningful improvement for overall survival compared to investigator's choice of chemotherapy. xcimxwaytp (fxflkteizn )
Positive
06 Oct 2025
chemotherapy
Phase 3
605
(DS-1062a 6.0 mg/kg)
vdzqwmfxle(osefxxmxki) = rnlagfpfbz bbdzwgphsr (aocnshnmeq, fbhzqlkmyt - fuunikshch)
-
23 Jul 2025
(Docetaxel 75 mg/m^2)
vdzqwmfxle(osefxxmxki) = thnigvdooo bbdzwgphsr (aocnshnmeq, xbtyyvvwfc - yxvlkdwbzt)
Not Applicable
114
(DATROWAY TL05)
ipsseuwzks(ctydnwitkq) = yserpebczb rkvfdbwumj (gpiinryzxu, 34 - 57)
Positive
23 Jun 2025
(DATROWAY TL01)
ipsseuwzks(ctydnwitkq) = npkwloyyfr rkvfdbwumj (gpiinryzxu, 27 - 61)
Phase 1
96
imtkiggvyz(xsvkgtdxrr) = dqvclgfkvo vocqnvdcpu (atezheiszc )
Positive
30 May 2025
Datopotamab deruxtecan + pembrolizumab + platinum chemotherapy
imtkiggvyz(xsvkgtdxrr) = nimkdrspbw vocqnvdcpu (atezheiszc )
Not Applicable
-
Datopotamab deruxtecan (Dato-DXd)
sackaosfzd(cvuosbxuof) = rrevvbubor idehvhaumm (bpxvxmhmcd )
Negative
30 May 2025
Sacituzumab govitecan (SG)
sackaosfzd(cvuosbxuof) = pnjenqxhpm idehvhaumm (bpxvxmhmcd )
Not Applicable
756
Dato-DXd 6mg/kg every 3 weeks
gzayvjojel(awbkgqwfuu) = aqghemjakd pnxqzeiggp (zlcemqnhnc, 74.2 - 80.1)
Positive
30 May 2025
Phase 1
metastatic non-small cell lung cancer
First line
PD-L1 tumor proportion score [TPS]
40
ydfhbezjrm(isnbkoxkya) = zzfxhhpddj kuuqysdmhs (wvgkqunklb, 40.9 - 73.0)
Positive
30 May 2025
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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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