Skip to main content

Margenza FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 2, 2021.

FDA Approved: Yes (First approved December 16, 2020)
Brand name: Margenza
Generic name: margetuximab-cmkb
Dosage form: Injection
Company: MacroGenics, Inc.
Treatment for: Breast Cancer

Margenza (margetuximab-cmkb) is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2- positive breast cancer.

Development timeline for Margenza

DateArticle
Dec 16, 2020Approval FDA Approves Margenza (margetuximab-cmkb) for Patients with Pretreated Metastatic HER2-Positive Breast Cancer
Dec 19, 2019MacroGenics Announces Submission of Margetuximab Biologics License Application to U.S. FDA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.