What is Margenza™ (margetuximab-cmkb)?

The U.S. Food and Drug Association (FDA) has approved Margenza™ (margetuximab-cmkb) to be used together with chemotherapy. It is approved to treat adults with metastatic HER2-positive breast cancer who have previously been treated with at least 2 other therapies that target HER2 regimens, with at least 1 of these therapies having been used to treat metastatic breast cancer. Metastatic cancer happens when cancer has spread from the part of the body where it started to another part or parts of the body. Margenza, made by the drug company MacroGenics, is an Fc-engineered monoclonal antibody that targets the HER2 oncoprotein.1,2

What is the active ingredient in Margenza?

The active ingredient in Margenza is margetuximab-cmkb.1,2

How does Margenza work?

Margenza targets the HER2 protein, helping to decrease the growth and spread of cancer cells. HER2 stands for human epidermal growth factor receptor 2. HER2 is a gene that makes the HER2 protein located on the surface of breast cells. It helps with the normal growth of these cells.1,3,8

Some cancers, especially breast cancer, can result when the HER2 gene changes and makes extra copies of the gene. This causes an increase in the amount of HER2 protein made, which leads to abnormal growth of cells. Cancers with a high level of HER2 protein are considered HER2-positive.3

Antibodies are proteins made by the immune system to fight infection or disease. Typically, 1 part of the antibody recognizes the harmful substance, while the other part of the antibody (known as Fc) interacts with the immune system to fight the infection or disease. Fc-engineering helps maximize the functions of these antibodies, making them useful as medicines and treatments.4-6

What are the possible side effects of Margenza?

The most common side effects of Margenza plus chemotherapy include7:

  • Fatigue
  • Nausea and vomiting
  • Diarrhea or constipation
  • Headache
  • Hair loss (alopecia)
  • Abdominal pain
  • Peripheral neuropathy
  • Cough
  • Decreased appetite
  • Muscle, joint, and/or arm/leg pain
  • Fever
  • Shortness of breath
  • Tenderness, redness, and/or pain on the bottom of the feet and/or palms of the hands

Margenza may also cause infusion-related reactions (IRRs). Symptoms may include7:

  • Fevers, chills, body aches
  • Cough
  • Dizziness
  • Fatigue
  • Nausea, vomiting
  • Low blood pressure

Margenza has a boxed warning, the strictest warning from the FDA, because of its potential to cause left ventricular dysfunction (part of your heart not functioning well) and toxicity to unborn babies. Reductions in left ventricular ejection fraction (LVEF) can be a potential sign of heart failure. Your doctor will need to monitor your heart function before and throughout treatment.1,7,9

If you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed, talk with your doctor. Margenza can cause harm to an unborn baby and should not be given to women who are pregnant. Women of childbearing age taking Margenza should use birth control during treatment and for 4 months following their last dose of the drug. Talk with your doctor about birth control options and breastfeeding before taking Margenza.8

These are not all the possible side effects of Margenza. Talk to your doctor about what to expect or if you experience any changes that worry you.

Things to know about Margenza

MacroGenics anticipates that Margenza will be available for treating people with breast cancer in March 2021.9

Before taking Margenza, tell your doctor about any other health conditions you have. Also tell your doctor about any drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Margenza.

By providing your email address, you are agreeing to our privacy policy. We never sell or share your email address.

Written by: Editorial Team | Last reviewed: December 2020