Last update 19 Aug 2025

Datopotamab Deruxtecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Dato-DXd, Datopotamab Deruxtecan-dlnk, 达托波单抗德鲁特卡
+ [7]
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
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Priority Review (United States)
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Structure/Sequence

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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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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
10 top R&D records.
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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 3-26 Sep 2025
Metastatic urothelial carcinomaPhase 3-26 Sep 2025
Transitional Cell CarcinomaPhase 3-26 Sep 2025
Urothelial Carcinoma of the Urinary BladderPhase 3-26 Sep 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
605
(DS-1062a 6.0 mg/kg)
sfaeifkfqm(xotjjgezmb) = pgjjqxjqgh yzcwfwxqny (besiofdybc, vptnaqunhe - xsvwktssqs)
-
23 Jul 2025
(Docetaxel 75 mg/m^2)
sfaeifkfqm(xotjjgezmb) = zutedqmpbd yzcwfwxqny (besiofdybc, cbnfwwllzs - elyklmkspl)
Not Applicable
114
(DATROWAY TL05)
ibtuiuczmk(vafieunnjd) = jtnebqkrki pcxqvrztsi (tdccvbbdnt, 34 - 57)
Positive
23 Jun 2025
(DATROWAY TL01)
ibtuiuczmk(vafieunnjd) = wxkilwrsqu pcxqvrztsi (tdccvbbdnt, 27 - 61)
Phase 1
96
dnnhbvbqqp(lbfuedozoe) = flnymycrve ysajlaxpns (qclaybcubz )
Positive
30 May 2025
Datopotamab deruxtecan + pembrolizumab + platinum chemotherapy
dnnhbvbqqp(lbfuedozoe) = cmncohwqte ysajlaxpns (qclaybcubz )
Not Applicable
9,307
sacituzumab govitecan (SG)
gnzefxdutq(mhymothyrb) = bftaocrpym nikntpumdk (yzjmeflags, 26.7)
Positive
30 May 2025
ofqnjcpgbp(uiyrkeghfm) = ambznafkrx wqgsfmxmjh (pthywzbolo )
Not Applicable
-
Datopotamab deruxtecan (Dato-DXd)
ihbucqvvct(czvjwlztbq) = pbpbqkwruj ycjkjktpgl (ulvxbhzbxw )
Negative
30 May 2025
Sacituzumab govitecan (SG)
ihbucqvvct(czvjwlztbq) = huwrqhhfkw ycjkjktpgl (ulvxbhzbxw )
Not Applicable
756
Dato-DXd 6mg/kg every 3 weeks
xirygdixxu(cwxzzlidrz) = kbrhjzbfsb lgqujqaeks (fgwdbteloz, 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
vniawnqlxf(jzykkbhalf) = gfknqwxvnm qbreukkwdd (okfnxvbhco, 40.9 - 73.0)
Positive
30 May 2025
Phase 2
69
Osimertinib (80 mg QD) + Datopotamab Deruxtecan (4 mg/kg Q3W)
zpkfgtnxzv(vtqtzsefmf) = pqgydcdmka pqlagqnmus (mnrvzhxvpd, 31 - 55)
Positive
26 Mar 2025
Osimertinib (80 mg QD) + Datopotamab Deruxtecan (6 mg/kg Q3W)
zpkfgtnxzv(vtqtzsefmf) = lfubyppykz pqlagqnmus (mnrvzhxvpd, 25 - 49)
Phase 1/2
Non-Small Cell Lung Cancer
TROP2 quantitative continuous scoring (QCS) normalised membrane ratio (NMR)
40
(TROP2 QCS-NMR+ tumors)
raybeappxz(fsjgeaoklw) = lfffpiybbq myqvvsveor (axvoovtpfc, 0.32 - 0.77)
Positive
26 Mar 2025
(TROP2 QCS-NMR- tumors)
raybeappxz(fsjgeaoklw) = gmglovfoln myqvvsveor (axvoovtpfc, 0.10 - 0.53)
Phase 3
468
rlldqgyxvz(uvlvjtbqpo): HR = 1.64 (95% CI, 1.09 - 2.46)
Positive
26 Mar 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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