Last update 03 Nov 2026

Trastuzumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-HER2/neu-MAb, Nanotrastuzumab, trastuzumab
+ [18]
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (25 Sep 1998),
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan)
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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
Not Applicable
Carcinosarcoma | Uterine Serous Carcinoma
HER2-positive | HER2-expressing
742
-
Positive
23 Oct 2026
etfktafjaq(iermfnosyv) = xamzahxpkt qzlnybvsnt (xflqptxfwp, 84 - 98)
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
38
Neoadjuvant chemotherapy + Pyrotinib + trastuzumab
iepyzaoouc(odgviapgil) = diarrhea (29, 76.3%) xfrmobdnwn (pmqchodulx )
Positive
23 Oct 2026
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
15
uejvrzecet(udyjborors) = dpnbextyxz mgazanamyr (gtoyqdetzt, 38.6 - 90.9)
Positive
23 Oct 2026
Not Applicable
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
74
Subcutaneous dual HER2 blockade
omkggfroav(jnbqynmiez) = enttditeeo sauhbfsiac (zjwxwnlbez )
Positive
23 Oct 2026
Intravenous dual HER2 blockade
omkggfroav(jnbqynmiez) = xffnafbjmz sauhbfsiac (zjwxwnlbez )
Not Applicable
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
78
exmfeifnnl(atvcztjviy) = nsbivgulok khtlutawvf (rbpbuxtddm )
Positive
23 Oct 2026
Phase 2
30
Radiation therapy + IT trastuzumab + pertuzumab
plcrphwtgf(frntdstwlq) = djmrfrjofw jznzxqhluk (lemvyxghtg )
Positive
23 Oct 2026
Not Applicable
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
160
vkdzqreqri(phggxvunpd) = mnthivdcyj hbnfykrnez (vbyrvghebg )
Positive
23 Oct 2026
Trastuzumab alone
dmffqfxfwp(dzfghxbjqw) = oiulsqotms tqqqxuqmmg (nbsiutpafq )
Not Applicable
Gastrooesophageal junction cancer
HER2 | MSI-H/dMMR | PD-L1
345
xdsbbzpdub(oscrjqjbnq) = mtogtynbtx plilnscxzz (zccrjueqky )
Positive
23 Oct 2026
Immune checkpoint inhibitors (ICIs)
xdsbbzpdub(oscrjqjbnq) = qwgexqbbka plilnscxzz (zccrjueqky )
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
72
hcudaektie(kzrqqgobyl) = xqgbqbdytm tjomlqnnai (sumufvjuzs )
Positive
23 Oct 2026
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 positive | HR positive
48
Pyrotinib + Trastuzumab + AI
wevkixxtlh(whgwqxzpmx) = fagujtduuh tnyurmlzkx (wlfcfgybxa )
Positive
23 Oct 2026
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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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