The FDA approved margetuximab-cmkb (Margenza, MacroGenics) in combination with chemotherapy for the treatment of adults with metastatic HER2-positive breast cancer who have received two or more anti-HER2 regimens, at least one of which was for metastatic disease.
The approval was based on results from the randomized, multicenter, open-label SOPHIA trial (ClinicalTrials.gov Identifier: NCT02492711). In the trial, 536 patients with immunohistochemistry 3+ or in situ hy-bridization–amplified