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

 

Totality of evidence for OGIVRI is based upon analytical similarity, clinical similarity and extrapolation to reference trastuzumab3

OGIVRI is available in single (150 mg) and multi-dose (420 mg) vials

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May reduce drug wastage13 and provide flexibility to choose the right formulation for individual practices

Indications

 
 

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
*High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3. For all indications, select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
 
  • 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
For all indications, select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
 

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

For all indications, select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
 

Based on the totality of the biosimilarity evidence for OGIVRI, FDA has approved the extrapolated indications of HER2+ early breast cancer and gastric cancer3

FDA: Food and Drug Administration; ER: Estrogen receptor; HER2: Human epidermal growth factor receptor 2; PR: Progesterone receptor