Therapeutic Response

HER2-positive status confers therapeutic sensitivity to Gemcitabine in combination with Margetuximab in patients with Invasive Breast Carcinoma.

Statements

Source and description

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