Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to margetuximab-cmkb 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 indication is based on SOPHIA (NCT02492711), a randomized, multicenter, open-label trial of 536 patients with IHC 3+ or ISH-amplified HER2+ metastatic breast cancer who had received prior treatment with other anti-HER2 therapies. Randomization within the trial was stratified by chemotherapy choice (capecitabine, eribulin, gemcitabine, or vinorelbine).

This is written in the approval document as:

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.

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.

Therapeutic response

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

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.