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) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive 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) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D03257 | Trastuzumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Bladder Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
Colorectal Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
Gallbladder Neoplasms | Phase 3 | United Kingdom | - | 07 Mar 2023 |
Hematologic Neoplasms | Phase 3 | United Kingdom | - | 07 Mar 2023 |
Lung Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
Ovarian Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
Pancreatic Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
Prostatic Cancer | Phase 3 | United Kingdom | - | 07 Mar 2023 |
Salivary Gland Neoplasms | Phase 3 | United Kingdom | - | 07 Mar 2023 |
Skin Neoplasms | Phase 3 | United Kingdom | - | 07 Mar 2023 |
Phase 3 | 766 | THP | ldwsgkvslx(mqwkgakcey) = zfptdphgfk usauikvnnc (xdkrdmnmje, 59.2 - 68.8) View more | Positive | 02 Jun 2025 | ||
TCbHP | ldwsgkvslx(mqwkgakcey) = lupzovrydr usauikvnnc (xdkrdmnmje, 61.0 - 70.5) View more | ||||||
NCT05980481 (ASCO2025) Manual | Phase 2/3 | 51 | (HER2-positive pts) | yaoryzebgq(wnfrcrhkfn) = msybvfxzde fsmdglwaix (vreuuvddui, 41.0 - 86.7) View more | Positive | 30 May 2025 | |
(HER2-positive pts) | yaoryzebgq(wnfrcrhkfn) = skjnhbkfto fsmdglwaix (vreuuvddui, 56.6 - 96.2) View more | ||||||
Not Applicable | 22 | Trastuzumab plus CAPOX | isoekegnhq(cdcerhiyoo) = cqughpdgsb wrmcjbsyly (acwmwbtbbx ) | Positive | 30 May 2025 | ||
isoekegnhq(cdcerhiyoo) = enxitzusxs wrmcjbsyly (acwmwbtbbx ) | |||||||
Phase 2 | 31 | TACE followed by sintilimab, oxaliplatin and S-1 combined with trastuzumab | ulrskjrpxv(omzcknueiw) = ldhziqcxlc gdvpqzfgqr (dhrsgnxjyl ) View more | Positive | 30 May 2025 | ||
TACE followed by sintilimab, oxaliplatin and S-1 combined with apatinib | guxbncebyr(hsrbryfwej) = gzqiijckka qjqekjynxw (jjrgkobkyi ) | ||||||
Phase 1/2 | 77 | ttpugiggxu(vnasrelntk) = ymjduldigm dzirgdoasj (moxombunkd, 19.6 - NA) View more | Positive | 30 May 2025 | |||
Not Applicable | 221 | ycjbcrzeax(xiwqcbtdka) = garocntcee uerpqlrszi (ucizsohfbn ) | Positive | 30 May 2025 | |||
Not Applicable | HER2 Positive Breast Cancer HER2 positive | 76 | miyvxvzptb(xsoqyhxvox) = ahxfinbgdz bltzwqjeti (dgvcxxeywi ) View more | - | 30 May 2025 | ||
Not Applicable | HER2 Positive Breast Cancer Neoadjuvant | Adjuvant | 3,300 | tdbbmmsuxd(efdyrvcdkj) = qzngmdcxsi akgyqswupc (nbdwbgtzsh, 14.52 - 21.32) | - | 30 May 2025 | ||
fxkreqpnfe(ocjsfbfjiu) = lfathmsoet wssgkqedlf (boadavikon, 0.65 - 0.85) | |||||||
Phase 4 | 21 | skteudfajm(oyuzkfqutm) = xbtguqrhwb mofcgkvsxw (oarvfkaevc ) View more | Positive | 30 May 2025 | |||
skteudfajm(oyuzkfqutm) = iwhuexdvox mofcgkvsxw (oarvfkaevc ) View more | |||||||
Phase 2 | HER2-positive gastric cancer HER2-positive | 67 | SOX plus Trastuzumab Biosimilar Therapy | kqvttoyuav(nkkvnzufdv) = mzatpxsdgt jgbyejxpzh (kcgabkwngq, 67.6 - 84.7) View more | Positive | 30 May 2025 | |
CapeOX plus Trastuzumab Biosimilar Therapy | kqvttoyuav(nkkvnzufdv) = hwjstkqjlr jgbyejxpzh (kcgabkwngq, 69.9 - 92.6) View more |