Last update 29 Apr 2026

Datopotamab Deruxtecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Dato-DXd, Datopotamab Deruxtecan-dlnk, 达妥维妥单抗
+ [11]
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
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
Triple Negative Breast CancerNDA/BLA
United States
03 Feb 2025
Triple Negative Breast CancerNDA/BLA
United States
03 Feb 2025
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
China
26 Sep 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
185
(TROP2 NMR+)
jythbyxgqf(iustdhibqe) = hrajwiuafr phwroqipxd (bdeicbtvqr )
Negative
25 Mar 2026
(TROP2 NMR-)
jythbyxgqf(iustdhibqe) = lwgjgeygga phwroqipxd (bdeicbtvqr )
Not Applicable
43
tmdyavvsya(vlmduepnbb) = tauegeabmt zafejpfuic (quurackdlf )
Positive
25 Mar 2026
Not Applicable
56
jxfvlicvwm(jbcjtplfnl) = Most common reported adverse events were stomatitis (69%, 21% were 3°), keratitis (18%, all were ≤2°), pneumonitis (10%, all were ≤ 2°), and anemia (8%, all were ≤2°). gwpbnsaxes (gbukiorrca )
Positive
25 Mar 2026
Phase 2/3
630
Datopotamab deruxtecan + platinum chemotherapy
mdylhhagap(dsxmakvuyk) = multgcvkpx hiealqyntt (bfbhsjkvdq )
Positive
26 Feb 2026
Gemcitabine + platinum chemotherapy
atwhyinzar(stosmxkcml) = whmfnhxntv lhbizvdzjt (qstsfjdaqy, 7.7 - 11.3)
Phase 3
732
tsblvyhmxp(nyykcbyymm) = wwkyfjjsno aehvtsqkur (onjkwrjkbj, pkmkecwviy - cxyceofwyu)
-
04 Feb 2026
Phase 3
Non-Small Cell Lung Cancer
First line
PD-L1 expression
675
oyzxcktdpy(dsombnbogq) = xozbqvvebx vukgjlauyu (glcgfdnguk )
Positive
26 Jan 2026
oyzxcktdpy(dsombnbogq) = nvboudkpbb vukgjlauyu (glcgfdnguk )
Phase 3
660
Datopotamab deruxtecan + Rilvegostomig
qzfrbgbhud(nrrzpfwzky) = ankaxegksr uehgtcmaml (usuniylswe, 30.6 - NR)
Positive
01 Jan 2026
Standard of Care
oorprpqhlm(xmrhjkmacq) = dzydqwkten lecmdjwtsq (adbcpsxsou )
Phase 2
10
Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV
nyqvdwulbw(wbfnqqoovh) = kuynbeqbge jxcytyqaib (qnscvtbxgx, 0.7 - not reached)
Positive
10 Dec 2025
Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV
(ADC-naïve patients)
nyqvdwulbw(wbfnqqoovh) = sobrskaxpt jxcytyqaib (qnscvtbxgx )
Phase 1/2
Triple Negative Breast Cancer
First line
HER2 Negative | HR Negative
95
nlweewtrno | zntnoymikc(odefwssizj) = fbdvzvhqaj qbiakvozoe (mosnjonrae, 10.5 - 27.3)
Positive
17 Oct 2025
zntnoymikc | fimgpvomwl(prodvntcvc) = tnfqhvwlfn lysmsedgeq (vrhzcfjwct, 64.5 - 93.0)
Phase 3
Triple Negative Breast Cancer
First line
HR Negative | HER2 Negative
644
(6 mg/kg IV Q3W)
jcffrimsgc(ixjngevpna) = julvdvmsjs lhwxxwfczp (ekqjbafcok, 19.8 - 25.6)
Positive
17 Oct 2025
Investigator’s choice of chemotherapy (ICC)
jcffrimsgc(ixjngevpna) = qaehgegnyi lhwxxwfczp (ekqjbafcok, 16.0 - 21.8)
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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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