Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) HER2-positive Invasive Breast Carcinoma Capecitabine, Margetuximab
FDA (2) HER2-positive Invasive Breast Carcinoma Eribulin, Margetuximab
FDA (2) HER2-positive Invasive Breast Carcinoma Gemcitabine, Margetuximab
FDA (2) HER2-positive Invasive Breast Carcinoma Margetuximab, Vinorelbine

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals
2020-12-16 Food and Drug Administration Indication received traditional approval.