Margenza (margetuximab-cmkb) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

MacroGenics, Inc. Margenza (margetuximab-cmkb) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761150s005lbl.pdf. Revised May 2023. Accessed October 30, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	4

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Capecitabine, Margetuximab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Eribulin, Margetuximab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Gemcitabine, Margetuximab
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Margetuximab, Vinorelbine