FDA Approves 420-mg Multi-Dose Vial of Trastuzumab Biosimilar

Officials with the FDA have approved a 420-mg multi-dose of trastuzumab-bttb (Ontruzant, Samsung Bioepis), a biosimilar referencing trastuzumab (Herceptin), according to a press release.

The biosimilar product is now approved in both 150-mg and 420-mg vials; trastuzumab-bttb was first granted approval as a 150-mg single-dose vial by the FDA in January 2019 across all eligible indications.

Trastuzumab is indicated for the adjuvant treatment of human epidermal growth factor receptor (HER)2-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.

In HER2-overexpressing node-positive or node-negative breast cancer, trastuzumab-dttb can be used as part of a treatment regimen containing doxorubicin, cylophosphamide, and either paclitaxel or docetaxel; with docetaxel and carboplatin; or as a single agent following mult-modality anthracycline-based therapy.

Common adverse reactions associated with trastuzumab in breast cancer include fever, nausea, vomiting, infusion reactions diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. In metastatic gastric cancer, the most common adverse reactions were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.

Trastuzumab will be marketed and distributed in the United States by Merck.