MacroGenics Gets Nod For Margenza In HER2-Positive Breast Cancer

Company Reaches Milestone With First FDA Approval

The drug may see a muted launch given the competitive landscape and a broad label despite its efficacy advantage in F-allele patients.

Doctor with Mammography - Image — MacroGenics won its first FDA approval, for Margenza in HER2-positive breast cancer • Source: Shutterstock

MacroGenics, Inc. could see a relatively muted entry into the marketplace for its bispecific antibody Margenza, at least early on, given the competitive landscape for HER2-positive metastatic breast cancer and that Margenza’s label features the full trial results rather than the targeted subgroup of patients with the CD16 158F allele, which most people carry and which is associated with a muted response to Genentech, Inc. ’s Herceptin (trastuzumab), a widely used HER2-targeting drug.

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