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Trastuzumab

Generic Name
Trastuzumab
Brand Names
Herceptin, Herceptin Hylecta, Herzuma, Kanjinti, Ontruzant, Perjeta-Herceptin, Phesgo, Trazimera, Herwenda, Ogivri, Zercepac, Tuznue, Dazublys
Drug Type
Biotech
CAS Number
180288-69-1
Unique Ingredient Identifier
P188ANX8CK

Overview

Produced in CHO cell cultures, trastuzumab is a recombinant IgG1 kappa, humanized monoclonal antibody that selectively binds with high affinity in a cell-based assay (Kd = 5 nM) to the extracellular domain of the human epidermal growth factor receptor protein (HER2). It is used as a treatment of human epidermal growth factor receptor (HER)-2+ metastatic breast cancer, where there is a proven amplification of the HER-2 oncogene or over-expression of the HER-2 protein in tumours. It is suggested that the overexpression or gene amplification of HER2 has been found in about 20–30% of breast cancers and elevated activation of HER2 triggers multiple downstream pathways leading to abnormal proliferation of cancer cells . Trastuzumab binds to HER2 and suppresses cancer cell growth, proliferation, and survival directly and indirectly . In December 2017, FDA approved OGIVRI (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). It displays biosimilar properties as Herceptin according to clinical data. While Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer, it is the second biosimilar approved in the U.S. for the treatment of cancer. Herzuma (trastuzumab-pkrb) is a biosimilar drug approved in December 2018 for the treatment of HER2-overexpressing breast cancer. KANJINTI (trastuzumab-anns) is another biosimilar approved by the FDA in June 2019. ONTRUZANT, another biosimilar of Herceptin, was approved by Health Canada in February 2022.

Indication

For the adjuvant treatment of HER2-overexpressing breast cancer, trastuzumab is indicated in several clinical settings: as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; or as monotherapy following multi-modality anthracycline-based therapy. Trastuzumab is indicated as a first-line treatment, in combination with paclitaxel, for metastatic HER2-overexpressing breast cancer, and as monotherapy in patients who have previously received one or more chemotherapy regimens in the metastatic setting. Trastuzumab is also indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. Trastuzumab is indicated for subcutaneous administration - in combination with either hyaluronidase or both hyaluronidase and pertuzumab - for the treatment of adults with HER2-positive breast cancers.

Associated Conditions

  • Breast Cancer
  • Inflammatory Breast Cancer (IBC)
  • Locally Advanced Breast Cancer (LABC)
  • Metastatic Adenocarcinoma of the Gastroesophageal Junction
  • Metastatic Adenocarcinoma of the Stomach
  • Metastatic Breast Cancer
  • Metastatic Gastric Adenocarcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Stage I Breast Cancer

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/12
Not Applicable
Not yet recruiting
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2025/08/03
Not Applicable
Not yet recruiting
2025/07/30
Not Applicable
Not yet recruiting
Shandong Cancer Hospital and Institute
2025/07/17
Not Applicable
Recruiting
2025/07/17
Not Applicable
Not yet recruiting
Gemma Biotherapeutics
2025/07/14
Not Applicable
Recruiting
2025/07/09
Not Applicable
Recruiting
2025/06/22
N/A
Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
2025/06/06
Phase 3
Recruiting
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
2025/06/06
Phase 1
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Amgen Inc
55513-132
INTRAVENOUS
420 mg in 20 mL
3/22/2024
Biocon Biologics Inc.
83257-003
INTRAVENOUS
420 mg in 20 mL
1/19/2024
Cephalon, Inc.
63459-303
INTRAVENOUS
150 mg in 7.15 mL
2/6/2023
Genentech, Inc.
50242-132
INTRAVENOUS
150 mg in 7.4 mL
10/19/2020
Genentech, Inc.
50242-245
SUBCUTANEOUS
600 mg in 15 mL
11/16/2022
Organon LLC
78206-147
INTRAVENOUS
150 mg in 1 1
1/31/2023
Amgen Inc
55513-141
INTRAVENOUS
150 mg in 7.15 mL
3/22/2024
Mylan Institutional LLC
67457-991
INTRAVENOUS
150 mg in 7.4 mL
2/8/2021
Genentech, Inc.
50242-260
SUBCUTANEOUS
600 mg in 10 mL
11/16/2022
Pfizer Laboratories Div Pfizer Inc
0069-0308
INTRAVENOUS
150 mg in 7.15 mL
2/14/2022

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
TRAZIMERA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 440MG/ VIAL
SIN16038P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
440 mg/vial
11/11/2020
CANHERA® LYOPHILIZED POWDER FOR INJECTION 440MG PER VIAL
SIN16384P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
440 mg/vial
11/25/2021
KANJINTI POWDER FOR INJECTION 440 MG/VIAL
SIN16207P
INJECTION, POWDER, FOR SOLUTION
440mg/vial
5/25/2021
HERZUMA® 150MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
SIN15838P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
150 mg/vial
10/29/2019
TRAZHER (Trastuzumab) Powder for Concentrate for Solution for Infusion 420mg/vial
SIN16898P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
420 mg/vial
11/22/2023
HERCEPTIN SOLUTION FOR INJECTION 600MG/5ML
SIN14867P
INJECTION, SOLUTION
600mg
10/9/2015
OGIVRI™ LYOPHILIZED POWDER FOR INJECTION 440MG PER VIAL
SIN15850P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
440 mg/vial
11/4/2019
KANJINTI POWDER FOR INJECTION 150 MG/VIAL
SIN16206P
INJECTION, POWDER, FOR SOLUTION
150mg/vial
5/25/2021
HERCEPTIN POWDER FOR INJECTION 440 mg/vial
SIN11028P
INJECTION, POWDER, FOR SOLUTION
440 mg/vial
7/19/1999
PHESGO SOLUTION FOR SUBCUTANEOUS INJECTION 1200 MG/600 MG / 15 ML
SIN16247P
INJECTION, SOLUTION
600 mg
6/22/2021

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ADHEROZA
02550970
Powder For Solution - Intravenous
150 MG / VIAL
N/A
TRAZIMERA
02483475
Powder For Solution - Intravenous
150 MG / VIAL
10/22/2019
OGIVRI
02474433
Powder For Solution - Intravenous
440 MG / VIAL
6/6/2019
OGIVRI
02474425
Powder For Solution - Intravenous
150 MG / VIAL
6/6/2019
HERZUMA
02480794
Powder For Solution ,  Kit - Intravenous
440 MG / VIAL
12/11/2019
PHESGO
Hoffmann-La Roche Limited
02512920
Solution - Subcutaneous
60 MG / ML
4/9/2021
KANJINTI
Amgen Canada Inc
02518244
Powder For Solution - Intravenous
150 MG / VIAL
10/7/2021
PERJETA-HERCEPTIN
Hoffmann-La Roche Limited
02405024
Kit ,  Solution ,  Powder For Solution - Intravenous
440 MG / VIAL
5/9/2013
HERCEPTIN SC
Hoffmann-La Roche Limited
02480697
Solution - Subcutaneous
600 MG / 5 ML
10/12/2018
ONTRUZANT
02524325
Powder For Solution - Intravenous
440 MG / VIAL
7/20/2022

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
HERZUMA 420 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
1171257002
POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
ZERCEPAC 60 mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
1201456002
POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
PHESGO 1200 MG/600 MG SOLUCION PARA INYECCION
1201497001IP
SOLUCIÓN INYECTABLE
Uso Hospitalario
Not Commercialized
PHESGO 600 MG/600 MG SOLUCION PARA INYECCION
1201497002IP
SOLUCIÓN INYECTABLE
Uso Hospitalario
Not Commercialized
KANJINTI 150 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
1181281001
POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
ZERCEPAC 420 mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
1201456003
POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
OGIVRI 150 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
1181341001
POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
HERCEPTIN 150 mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
00145001
POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
TRAZIMERA 420 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
1181295002
POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
TRAZIMERA 150 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
1181295001
POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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