margetuximab-cmkb
Drug Details
- Generic Name
- margetuximab-cmkb
- Brand Names
- MARGENZA
- Application Number
- BLA761150
- Sponsor
- TerSera Therapeutics LLC
- NDC Codes
- 2
- Dosage Forms
- INJECTION, SOLUTION, CONCENTRATE
- Routes
- INTRAVENOUS
- Active Ingredients
- MARGETUXIMAB
Indications and Usage
1 INDICATIONS AND USAGE MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ]. MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. ( 1 , 2.1 , 14.1 )