Quick answers
- What is Margetuximab-cmkb used for?
- The FDA-approved label (Margenza, TerSera Therapeutics LLC, February 11, 2025) says: “MARGENZA is 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 […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Margetuximab-cmkb have a boxed warning?
- Yes. The FDA label for Margenza has a boxed warning (“WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Margetuximab-cmkb?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Margetuximab-cmkb been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Margetuximab-cmkb?
- 2 companies list prescription products of Margetuximab-cmkb in the FDA NDC Directory, including MacroGenics, Inc and TerSera Therapeutics LLC.
What Margetuximab-cmkb is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MARGENZA is 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 […]. …
— FDA label: Margenza, TerSera Therapeutics LLC, effective February 11, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY
. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Margenza |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- MacroGenics, Inc1 product
- TerSera Therapeutics LLC1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761150 MARGENZA | Tersera Therapeutics LLC | December 16, 2020 | 2, latest January 15, 2025 2025: Labeling · 2023: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2474028, 2474033 |
|---|---|
| SPL set ID of the quoted label | 6a6d50c7-06ea-479c-83cc-f197a9e428c9 |
| FDA labels (SPL) | 2 |
| FDA applications | BLA761150 |
| Active ingredients (FDA) | MARGETUXIMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Margenza, TerSera Therapeutics LLC, effective February 11, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →