What is OGIVRI®?
First FDA-approved biosimilar trastuzumab for HER2+ adjuvant and metastatic breast and metastatic gastric cancers
OGIVRI (trastuzumab-dkst) is the first FDA approved biosimilar trastuzumab for HER2+ breast and gastric cancers1
Adjuvant treatment of 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
Based on the totality of the biosimilarity evidence for OGIVRI, FDA has approved the extrapolated indications of HER2+ early breast cancer and gastric cancer3FDA: Food and Drug Administration; ER: Estrogen receptor; HER2: Human epidermal growth factor receptor 2; PR: Progesterone receptor