FDA Approves Trastuzumab-dttb Biosimilar for Breast Cancer
Trastuzumab-dttb was first approved in January 2019 across all eligible indications, mainly adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer.
Officials from the FDA have approved a 420 mg multi-dose vial of trastuzumab-dttb (Ontruzant, Samsung Bioepis Co, Ltd), a biosimilar referencing trastuzumab (Herceptin).
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.
The most common adverse reactions for trastuzumab products in breast cancer include fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
For metastatic gastric cancer, adverse reactions were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.
Samsung Bioepis announces FDA approval of 420 mg multi-dose vial of Ontruzant® (trastuzumab-dttb) [news release]. Incheon, Korea; Samsung Bioepis: March 24, 2020 [email]. Accessed March 24, 2020.