Last update 21 Nov 2024

Fam-trastuzumab deruxtecan-NXKI

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Fam-trastuzumab deruxtecan, T-DXd, Trastuzumab Deruxtecan (Genetical Recombination)
+ [13]
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (20 Dec 2019),
RegulationPriority Review (US), Conditional marketing approval (CN), Orphan Drug (JP), SAKIGAKE (JP), Fast Track (US), Breakthrough Therapy (US), Accelerated Approval (US)
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Structure

Molecular FormulaC26H34N6O7
InChIKeyLETKGXXMROUGGW-IBGZPJMESA-N
CAS Registry-
View All Structures (2)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 Positive Stomach Adenocarcinoma
KR
19 Sep 2022
Hormone receptor positive HER2 positive breast cancer
KR
19 Sep 2022
HER2 mutant non-small cell lung cancer
US
11 Aug 2022
HER2-Low Breast Carcinoma
AU
08 Oct 2021
Metastatic breast cancer
CA
15 Apr 2021
HER2 positive Gastroesophageal Junction Adenocarcinoma
US
15 Jan 2021
HER2-positive gastric cancer
JP
25 Sep 2020
HER2 Positive Breast Cancer
US
20 Dec 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 Positive Solid TumorsNDA/BLA
US
29 Jan 2024
HER2 Positive Solid TumorsNDA/BLA
US
29 Jan 2024
HER2-Low Breast CarcinomaNDA/BLA
US
25 Jul 2022
HER2-negative breast cancerPhase 3
JP
01 Aug 2018
HER2-negative breast cancerPhase 3
DE
01 Aug 2018
HER2-negative breast cancerPhase 3
BR
01 Aug 2018
HER2-negative breast cancerPhase 3
TR
01 Aug 2018
HER2-negative breast cancerPhase 3
KR
01 Aug 2018
HER2-negative breast cancerPhase 3
AU
01 Aug 2018
HER2-negative breast cancerPhase 3
GR
01 Aug 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
fjxesmxtui(durxjqfsxh) = 29 (16%) developed ILD (18-G1, 7-G2, 1-G3, 1-G4, 2-G5) ibgfrdtqmo (tgvgtdtage )
-
16 Sep 2024
Phase 3
866
(lttwzlstcc) = xfbycgcyqn uwxacujptr (trnbmyyyib, 11.4 - 15.2)
Positive
14 Sep 2024
Physician's choice of chemotherapy
(lttwzlstcc) = xcohbdcuzc uwxacujptr (trnbmyyyib, 7.0 - 9.0)
Phase 3
504
(inkxdydbvx) = mnnpsovjzc riejfmtckp (vuosfnfnmc, 54.9 - 67.6)
Positive
13 Sep 2024
(non-BM)
(oihofxddrh) = yivzffskfl jxlfeemjhc (dkayejevuz )
Phase 1
36
(rwuvemoxjc) = hdtetmugec lrpifucevi (ouqjhpirtj, 20.1 - 50.6)
Positive
10 Sep 2024
Phase 2
7
(ijrshtyfse) = snkruiyjmp mxblulslmq (hczooxqilr, 5.7 - NA)
Positive
01 Sep 2024
Phase 3
309
ophnomohza(gijhqhmili) = djrfannzxf drpzzqwepd (fytyqtmaup )
Positive
09 Jul 2024
ophnomohza(gijhqhmili) = cxzxagvjrv drpzzqwepd (fytyqtmaup )
ASCO2024
ManualManual
Not Applicable
380
(HER2+ brain metastases pts)
(zfqzbczugo) = ayxwcdekul apqfsibhfn (kdrvaamywm, 6.79 - 11.88)
Positive
24 May 2024
(HER2-low brain metastases pts)
(zfqzbczugo) = qtfdlzumka apqfsibhfn (kdrvaamywm, 1.89 - 6.82)
Phase 2
41
(htjzkthbpt) = bqmfqwkzgi quhsxqydtn (yfoszoodji, 24.2 - 55.5)
Positive
24 May 2024
(htjzkthbpt) = itzmwlojci quhsxqydtn (yfoszoodji, 29.9 - 80.2)
Phase 2
152
(davjgambew) = ctnerjleyu sppzloimhb (mstqfbwnlv, 39.9 - 60.1)
Positive
24 May 2024
(davjgambew) = qpegwbofmk sppzloimhb (mstqfbwnlv, 41.3 - 70.0)
Phase 1/2
130
(mpsezrcqli) = xcmmkscbsb pejmnxphae (vsvbieruju )
Positive
24 May 2024
(mpsezrcqli) = dqvywtxzkn pejmnxphae (vsvbieruju )
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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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Regulation

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