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.
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.
Sun Yat Sen Memorial Hospital,Sun Yat sen University, Guangzhou, Guangdong, China
Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda, São Paulo, Brazil
Irmandade Da Santa Casa De Misericórdia De Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Nanfang Hospital, Southern Medical University, Guangzhou, China
First Hospital of China Medical University; Surgery, Shenyang City, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, China
Zhiyong Yu, Jinan, Shandong, China
Fudan University Cancer Hospital, Shanghai, Shanghai, China
Tianjin Medical University Cancer Institution & Hospital, Tianjin, Tianjin, China
Moffitt Cancer Center, Tampa, Florida, United States
Northwestern University, Evanston, Illinois, United States
I.R.S.T. Srl Irccs, Meldola, Italy
Ospedale Classificato Sacro Cuore - Don Calabria, Negrar, Italy
I.R.C.C.S. Istituto Oncologico Veneto, Padova, Italy
HealthPartners Institute, Saint Louis Park, Minnesota, United States
Texas Oncology, P.A. - Dallas, Dallas, Texas, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Charité - Universitätsmedizin Berlin, Berlin, Germany
Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg, Germany
Universitätsklinikum Freiburg, Freiburg, Germany
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