Last update 25 May 2025

Trastuzumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-HER2/neu-MAb, trastuzumab, Trastuzumab (Genetical Recombination)
+ [17]
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (25 Sep 1998),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 Positive Colorectal Cancer
Japan
28 Mar 2022
HER2 positive salivary gland cancer
Japan
25 Nov 2021
HER2-positive gastric cancer
Japan
10 Mar 2011
Stomach Cancer
United States
20 Oct 2010
Breast Cancer
Japan
04 Apr 2001
Early Stage Breast Carcinoma
European Union
28 Aug 2000
Early Stage Breast Carcinoma
Iceland
28 Aug 2000
Early Stage Breast Carcinoma
Liechtenstein
28 Aug 2000
Early Stage Breast Carcinoma
Norway
28 Aug 2000
HER2 Positive Breast Cancer
European Union
28 Aug 2000
HER2 Positive Breast Cancer
Iceland
28 Aug 2000
HER2 Positive Breast Cancer
Liechtenstein
28 Aug 2000
HER2 Positive Breast Cancer
Norway
28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma
European Union
28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma
Iceland
28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma
Liechtenstein
28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma
Norway
28 Aug 2000
Hormone receptor positive breast cancer
European Union
28 Aug 2000
Hormone receptor positive breast cancer
Iceland
28 Aug 2000
Hormone receptor positive breast cancer
Liechtenstein
28 Aug 2000
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Bladder CancerPhase 3
United Kingdom
-07 Mar 2023
Colorectal CancerPhase 3
United Kingdom
-07 Mar 2023
Gallbladder NeoplasmsPhase 3
United Kingdom
-07 Mar 2023
Hematologic NeoplasmsPhase 3
United Kingdom
-07 Mar 2023
Lung CancerPhase 3
United Kingdom
-07 Mar 2023
Ovarian CancerPhase 3
United Kingdom
-07 Mar 2023
Pancreatic CancerPhase 3
United Kingdom
-07 Mar 2023
Prostatic CancerPhase 3
United Kingdom
-07 Mar 2023
Salivary Gland NeoplasmsPhase 3
United Kingdom
-07 Mar 2023
Skin NeoplasmsPhase 3
United Kingdom
-07 Mar 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
HER2 Positive Breast Cancer
ERBB2 Mutation (Activating)
31
Tucatinib 300 mg PO BID + Trastuzumab 8 mg/kg IV followed by 6 mg/kg Q3W
bepffrthtt(viikujdaos) = wtzdrxptig unrqceplcv (qdjtfybfuq, 26.9 - 58.2)
Positive
16 May 2025
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 expression | HR status
285
HP + endocrine therapy
vipuumtiyt(mkgzznxufq) = The 3y-iDFS rate in pts with cT1/T2cN0 tumors was 98.3% (95%CI 96%-100%), with only two (1.7%) recurrences, one locoregional and one distant. qhmvsfhunt (yqclvethub )
Positive
14 May 2025
Not Applicable
58
ixccsxidma(ubktssonth) = chkxtgsdft cjqqhardlc (jlxcjnddip )
-
14 May 2025
Not Applicable
30,179,725
vtndgazgah(qdwhyilzxh) = The PRR was found to be 16.257 ( 5.147; 51.345 ), ROR was 16.259 ( 5.147; 51.357 ) and Chi-Square was 28.102 for fingerprint loss thgtroespk (qeljgormvs )
-
14 May 2025
Not Applicable
-
COPS5 inhibition with CSN5i-3
riitvdzdet(wqwipixzxo) = xidhhrbcwv buifbbnwkb (icxseufncz )
Positive
29 Apr 2025
riitvdzdet(wqwipixzxo) = hknfoqslae buifbbnwkb (icxseufncz )
Phase 2
46
zfwdqbsyhm(fqftydxztd) = dxfzqfkpfg aatyzjojnk (elhbobseqe )
Positive
23 Jan 2025
zfwdqbsyhm(fqftydxztd) = ktwyhunzmq aatyzjojnk (elhbobseqe )
Phase 2/3
127
usszjzmfwr(ucbjkbpdvn) = paiarecpqk orfzmtmlxa (zqelwcojhb )
Positive
23 Jan 2025
Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)
usszjzmfwr(ucbjkbpdvn) = luzxuzyzrx orfzmtmlxa (zqelwcojhb )
Phase 2
172
Chemotherapy alone
kqezlivrnr(pvhcdqgcoj) = jtaokofzgd hoiogfblji (rcgiiupxhh )
Negative
23 Jan 2025
Chemotherapy + Trastuzumab
kqezlivrnr(pvhcdqgcoj) = yuxthwrmzv hoiogfblji (rcgiiupxhh )
Phase 2
31
qknhqcjeaz(apbthxnrid) = pzbixskrkx vmdwenvduf (pqvtmncdsj, 26.9 - 58.2)
Positive
17 Jan 2025
Phase 2
RAS/BRAF Wild Type HER2 Positive Colorectal Cancer
Second line | Third line
HER2 Positive
54
wfdulqosul(kytyhonaly) = gvhuxikpto gsesxnvjmy (hmfkyjkryr, 1.9 - 7.6)
Positive
06 Jan 2025
wfdulqosul(kytyhonaly) = qjlgmbgovr gsesxnvjmy (hmfkyjkryr, 1.6 - 6.7)
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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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