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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.

Adverse Reactions

  • 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, 2019Approval FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin
Dec 20, 2017Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.