Trastuzumab Biosimilar Receives FDA Approval of Multidose Vial
Posted: Wednesday, April 1, 2020
On March 24, the U.S. Food and Drug Administration (FDA) gave approval for a 420-mg multidose vial of trastuzumab-dttb (Ontruzant)—a biosimilar to trastuzumab (Herceptin). It is indicated for the treatment of HER2-overexpressing node-positive or node-negative (estrogen receptor/progesterone receptor–negative or with one of the following high-risk features: tumor size > 2 cm, age < 35 years, or a tumor grade of 2 or 3) breast cancer and metastatic breast cancer. Trastuzumab-dttb can be given alone following multimodality anthracycline-based therapy; in combination with doxorubicin; cyclophosphamide and either paclitaxel or docetaxel; or with docetaxel and carboplatin together. The drug has also been approved for the treatment of patients with metastatic gastric cancer or patients with gastroesophageal junction adenocarcinoma who have not previously been treated for metastatic disease. This past July, the FDA approved a 150-mg single-dose vial of trastuzumab-dttb.
Clinical trials measuring the safety profile of trastuzumab products when combined with myelosuppressive chemotherapy showed grade 3 or 4 neutropenia and febrile neutropenia compared with participants who received chemotherapy alone. Common adverse reactions associated with trastuzumab products in breast cancer include fever, nausea, vomiting, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, anemia, and myalgia. Serious safety concerns for trastuzumab-dttb include cardiomyopathy, fatal infusion reactions, pulmonary toxicity, and embryofetal toxicity.
