FDA Approves Trastuzumab Biosimilar for Treatment of Advanced Breast Cancer
Posted: Tuesday, January 22, 2019
On January 18, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dttb (Ontruzant), a biosimilar referencing trastuzumab, across all eligible indications—namely, adjuvant treatment of 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, the third trastuzumab biosimilar to be approved by the FDA, was also approved by the European Commission in November 2017. It has since been launched in a growing number of European countries.
Trastuzumab-dttb is indicated for the adjuvant treatment of HER2-overexpressing node-positive or node-negative (estrogen receptor–/progesterone receptor–negative or with one high-risk feature) breast cancer as part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; with docetaxel and carboplatin; or as a single agent after multimodality anthracycline-based therapy.
In addition, trastuzumab-dttb is indicated in combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer; as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease; and in combination with cisplatin and capecitabine or fluorouracil for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.