Ontruzant FDA Approval History
Last updated by Judith Stewart, BPharm on May 19, 2020.
FDA Approved: Yes (First approved January 18, 2019)
Brand name: Ontruzant
Generic name: trastuzumab-dttb
Dosage form: for Injection
Company: Samsung Bioepis Co., Ltd.
Treatment for: Breast Cancer, Gastric Cancer
Ontruzant (trastuzumab-dttb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Indications and Usage
- Adjuvant Breast Cancer HER2 overexpressing node positive or node negative (ER/PR negative or with one 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
- as a single agent following multi-modality anthracycline based therapy.
- Metastatic Breast Cancer
- in combination with paclitaxel for 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.
- Metastatic Gastric Cancer 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.
- In these indications, patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
- Ontruzant is administered as an intravenous (IV) infusion.
- Adjuvant Breast Cancer - Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills.
- Metastatic Breast Cancer - Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
- Metastatic Gastric Cancer - Most common adverse reactions (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.
Ontruzant (trastuzumab-dttb) is the third FDA-approved trastuzumab biosimilar, following the approvals for Herzuma (trastuzumab-pkrb) in December 2018 and Ogivri (trastuzumab-dkst) in December 2017.
Development timeline for Ontruzant
|Jan 21, 2019||Approval FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin|
|Dec 20, 2017||Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration|
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