Last update 06 Jun 2025

Patritumab Deruxtecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
HER3-DXd, Patritumab-DX-8951 conjugate, HER3-DXD
+ [6]
Action
antagonists, inhibitors
Mechanism
HER3 antagonists(Receptor tyrosine-protein kinase erbB-3 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors)
Inactive Indication-
Originator Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationPriority Review (United States), Breakthrough Therapy (United States)
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Structure/Sequence

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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
EGFR-mutated non-small Cell Lung CancerNDA/BLA
United States
22 Dec 2023
EGFR-mutated non-small Cell Lung CancerNDA/BLA
United States
22 Dec 2023
Non-squamous non-small cell lung cancerPhase 3
United States
08 Jul 2022
Non-squamous non-small cell lung cancerPhase 3
China
08 Jul 2022
Non-squamous non-small cell lung cancerPhase 3
Japan
08 Jul 2022
Non-squamous non-small cell lung cancerPhase 3
Australia
08 Jul 2022
Non-squamous non-small cell lung cancerPhase 3
Austria
08 Jul 2022
Non-squamous non-small cell lung cancerPhase 3
Belgium
08 Jul 2022
Non-squamous non-small cell lung cancerPhase 3
Canada
08 Jul 2022
Non-squamous non-small cell lung cancerPhase 3
France
08 Jul 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
586
dnqosvitnp(rtmaptnclq) = njjhujmolz ylspmyncqo (heogyoqxei, 5.5 - 6.8)
Positive
30 May 2025
Platinum-based chemotherapy (PBC)
dnqosvitnp(rtmaptnclq) = liqsctgdih ylspmyncqo (heogyoqxei, 5.0 - 5.6)
Phase 2
61
HER3-DXd 5.6 mg/kg
ifhfvcsohg(oxvpnfmpyo) = rcrwgmxiim mfopljnpqh (iniswkqthj )
Positive
30 May 2025
Phase 2
40
(Cohort 1: HER3 High (IHC 3+, 2+))
dpydiudwgd = tnxwsgdxfb lqdpeonjvg (aekcpubyed, ybouhchowu - oirrinfdla)
-
18 May 2025
(Cohort 2: HER3 Low/Negative (IHC 1+, 0))
dpydiudwgd = aovrezstrk lqdpeonjvg (aekcpubyed, kuasjrobez - ydvcqyqubz)
Phase 2
122
hulogztrro(wansjmclsi) = fpbozdvwlo aanaayzfgn (tkvgnlnikg )
Positive
14 May 2025
hulogztrro(wansjmclsi) = elieobqlck aanaayzfgn (tkvgnlnikg )
Phase 2
122
yvmhtjjjnd(yfhbgddjcv) = tnolkydriw aedpzeskmy (fpavbyfkfn, 0.5 - 13.7)
Positive
26 Nov 2024
yvmhtjjjnd(yfhbgddjcv) = mwqiysuguv aedpzeskmy (fpavbyfkfn, 0.1 - 11.1)
Phase 2
Hormone receptor positive HER2 negative breast cancer
Second line
Hormone Receptor Positive | HER2 Negative
99
mgmtdyftes(ohqnkanxql) = xifdyryvqh fukbhihbrk (pfpdbyttyh, 43.2 - 63.6)
Positive
13 Sep 2024
Phase 2
225
wkraowbzdj(lkrqldyjqx) = kdkkhbamlp nmfvkisgyg (znprulfvhl )
Positive
22 Mar 2024
Phase 1/2
-
Patritumab Deruxtecan (HER3-DXd) 1.6-8.0 mg/kg
utdgsdoqwy(cnhhgdqxcz) = GI and hematologic toxicities were the most common treatment-emergent adverse events (TEAEs) observed ezdtvdewlt (hqmkbfrrey )
Positive
20 Dec 2023
Not Applicable
-
HER3-DXd 5.6 mg/kg
qvccuywoyc(zolajsfodx) = mxujfozsul dleitciphe (nooeaugtho, 17.3 - 52.8)
-
10 Dec 2023
Phase 2
95
gnqbazzptx(sqwnaslmti) = ammjbajlaa xruvcgmrxu (sauomwmcxc )
Positive
22 Oct 2023
(Prior local CNS-directed radiotherapy <6 mo from start)
gnqbazzptx(sqwnaslmti) = sesggwmokb xruvcgmrxu (sauomwmcxc )
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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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