What is the generic name?

TRASTUZUMAB

What is the Trade Name for TRASTUZUMAB?

OGIVRI

What are the Indications for TRASTUZUMAB?

• 1 INDICATIONS AND USAGE Ogivri is a HER2/neu receptor antagonist indicated for: ‚Ä¢ The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) ‚Ä¢ The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product ( 1 , 2.1 ). 1.1 Adjuvant Breast Cancer Ogivri is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer ‚Ä¢ as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel ‚Ä¢ as part of a treatment regimen with docetaxel and carboplatin ‚Ä¢ as a single agent following multi-modality anthracycline based therapy. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1) ]. 1.2 Metastatic Breast Cancer Ogivri is indicated: ‚Ä¢ In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer ‚Ä¢ As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1) ]. 1.3 Metastatic Gastric Cancer Ogivri is indicated, 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. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1) ] .

References: https://open.fda.gov/