margetuximab-cmkb

FDA Drug Profile — MARGENZA

margetuximab-cmkb is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including MARGENZA. Available dosage form: injection, solution, concentrate.

Drug Details

Generic Name
margetuximab-cmkb
Brand Names
MARGENZA
Application Number
BLA761150
Sponsor
MacroGenics, Inc
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 )