Trastuzumab-dttb was first approved as a 150 mg single-dose vial by the FDA in January 2019 across all eligible indications, mainly adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.
Trastuzumab-dttb is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative breast cancer, including:
• As a part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel.
• With docetaxel and carboplatin.
• As a single agent following multi-modality anthracycline-based therapy.
In addition, trastuzumab-dttb is indicated in combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer and as a single agent for the treatment of HER2-overexpressing breast cancer in patients who have received 1 or more chemotherapy regimens for metastatic disease.