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 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 5/16/2018 | ||
Authorised | 12/12/2018 | ||
Authorised | 12/21/2020 | ||
Authorised | 7/27/2020 | ||
Authorised | 7/26/2018 | ||
Authorised | 8/28/2000 | ||
Authorised | 11/15/2017 | ||
Authorised | 11/15/2023 | ||
Authorised | 9/19/2024 | ||
Authorised | 2/9/2018 |
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. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
HERCEPTIN SOLUTION FOR INJECTION 600MG/5ML (FOR SUBCUTANEOUS USE ONLY) | N/A | N/A | N/A | 11/18/2015 | |
PHESGO SOLUTION FOR SUBCUTANEOUS INJECTION 600MG/600MG IN 10ML | N/A | N/A | N/A | 6/25/2021 | |
HERCEPTIN POWDER FOR INJ 150MG | N/A | N/A | N/A | 12/31/2002 | |
HERCEPTIN POWDER & SOLVENT FOR INJ 440MG | N/A | N/A | N/A | 12/31/2002 | |
HERCEPTIN POWDER FOR INJ 150MG | N/A | N/A | N/A | 6/20/2008 | |
HERCEPTIN POWDER AND SOLVENT FOR INJECTION 440MG | N/A | N/A | N/A | 5/2/2014 | |
PHESGO SOLUTION FOR SUBCUTANEOUS INJECTION 1200MG/600MG IN 15ML | N/A | N/A | N/A | 6/25/2021 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
OGIVRI trastuzumab (rch) 440 mg powder for injection vial with bacteriostatic water for injection | 288223 | Medicine | A | 12/11/2018 | |
OGIVRI trastuzumab (rch) 150 mg powder for injection vial | 288222 | Medicine | A | 12/11/2018 | |
KANJINTI trastuzumab 150 mg powder for injection vial | 296881 | Medicine | A | 5/16/2019 | |
KANJINTI trastuzumab 420 mg powder for injection vial | 296883 | Medicine | A | 5/16/2019 | |
HERZUMA trastuzumab (rch) 150 mg powder for injection for intravenous infusion vial | 289146 | Medicine | A | 7/17/2018 | |
KANJINTI trastuzumab 60 mg powder for injection vial | 296882 | Medicine | A | 5/16/2019 | |
TRASTUCIP trastuzumab 150 mg powder for injection vial | 368972 | Medicine | A | 7/18/2022 | |
PHESGO SC pertuzumab (rch) 1200mg and trastuzumab (rch) 600mg in 15mL solution for injection, vials | 332180 | Medicine | A | 7/6/2021 | |
ONTRUZANT trastuzumab 150 mg powder for injection vial | 298457 | Medicine | A | 1/9/2019 | |
TUZUCIP trastuzumab 150 mg powder for injection vial | 368990 | Medicine | A | 7/18/2022 |
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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