Regulatory approval
Published by the Food and Drug Administration.
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.| 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 |