Last update 30 Jul 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)
Inactive Indication-
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
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
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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
Adenocarcinoma of LungPhase 3
United States
15 Oct 2024
Adenocarcinoma of LungPhase 3
Japan
15 Oct 2024
Adenocarcinoma of LungPhase 3
Belgium
15 Oct 2024
Adenocarcinoma of LungPhase 3
Brazil
15 Oct 2024
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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)
mezdqahjqk(qszasghksv) = kqidpqjcid rospootdck (tifaedlzxf, ktjcquvfqu - bdqveoubzb)
-
23 Jul 2025
(Docetaxel 75 mg/m^2)
mezdqahjqk(qszasghksv) = sjxlcdnplw rospootdck (tifaedlzxf, lnkhpgolvj - wicsaapmsa)
Not Applicable
114
(DATROWAY TL05)
dzdcbvvwgw(xeununltzo) = qatgmkvohh epkrablgqv (iadbttqdlc, 34 - 57)
Positive
23 Jun 2025
(DATROWAY TL01)
dzdcbvvwgw(xeununltzo) = agldslocqt epkrablgqv (iadbttqdlc, 27 - 61)
Phase 1
96
ocjxhlhyzg(nzryjgqljo) = pojibeylws qfafefvjqf (ejduovrbhj )
Positive
30 May 2025
Datopotamab deruxtecan + pembrolizumab + platinum chemotherapy
ocjxhlhyzg(nzryjgqljo) = gcadikaksd qfafefvjqf (ejduovrbhj )
Not Applicable
756
Dato-DXd 6mg/kg every 3 weeks
bfrfpnncji(dkzndapvxt) = ozqqkgdadj otqwefoatk (mpksscpbuz, 74.2 - 80.1)
Positive
30 May 2025
Not Applicable
-
Datopotamab deruxtecan (Dato-DXd)
oigftnvkfi(jsxpogvlvc) = rsjirazvtn ecpgpjkbvu (hovilgzanf )
Negative
30 May 2025
Sacituzumab govitecan (SG)
oigftnvkfi(jsxpogvlvc) = pjiowzrpue ecpgpjkbvu (hovilgzanf )
Phase 1
metastatic non-small cell lung cancer
First line
PD-L1 tumor proportion score [TPS]
40
ycxooqhupl(ndceeczqyh) = zrkjxeyqln sbcpqdskwc (fqfabbqgrj, 40.9 - 73.0)
Positive
30 May 2025
Not Applicable
9,307
sacituzumab govitecan (SG)
rldozmxyij(kqorlarkgo) = rhvdwdfjaa juhbfiqaef (wmejrfibwv, 26.7)
Positive
30 May 2025
tbkwstvqyj(dtnturhhko) = fqufelsvqo jmcdgropum (uwbcgfwpth )
Phase 2
metastatic non-small cell lung cancer
EGFR mutations | ALK rearrangements
137
Datopotamab deruxtecan 6 mg/kg
kqioocdlqb(fsjxfztrjk) = zktjtlxikc sjxaiegqoy (pnjzvmcqix, 27.8 - 44.4)
Positive
01 Apr 2025
Phase 2
69
Osimertinib (80 mg QD) + Datopotamab Deruxtecan (4 mg/kg Q3W)
fekavkettq(qxcyazlsmv) = texpesnjsc dzqbjfkwvx (thfrdzwetd, 31 - 55)
Positive
26 Mar 2025
Osimertinib (80 mg QD) + Datopotamab Deruxtecan (6 mg/kg Q3W)
fekavkettq(qxcyazlsmv) = jwtjroysis dzqbjfkwvx (thfrdzwetd, 25 - 49)
Not Applicable
914
Datopotamab deruxtecan 6 mg/kg
rxhvrvjthw(yqttipcgoj) = 7% mhalblrymb (fqxxveazja )
Positive
26 Mar 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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