The Food and Drug Administration (FDA) has approved a 420mg multidose vial of Ontruzant (trastuzumab-dttb; Samsung Bioepis), a biosimilar to Herceptin (trastuzumab; Genentech), adding to the 150mg single-dose vial originally approved in January 2019.
Ontruzant, an HER2/neu receptor antagonist, is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with 1 high risk feature breast cancer) as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; or as a single agent following multi-modality anthracycline based therapy.
In addition, it is approved for use in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, and as a single agent, for treatment of HER2-overexpressing breast cancer in patients who have received 1 or more chemotherapy regimens for metastatic disease.
Ontruzant is also indicated for use in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
Prior to treatment, HER2 testing using an FDA-approved companion diagnostic for a trastuzumab product should be performed. The product should not be substituted for or with ado-trastuzumab emtansine.
Ontruzant will be marketed and distributed in the US by Merck.
For more information visit merck.com.