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Margetuximab

Monoclonal antibody

Monoclonal antibody

FieldValue
typemab
mab_typemab
sourcexi/o
targetHER2
tradenameMargenza
DailyMedIDMargetuximab
pregnancy_AU
pregnancy_categoryNot recommended. Margetuximab can cause fetal harm when administered to a pregnant woman.
routes_of_administrationIntravenous
classHER2/neu receptor antagonist
ATC_prefixL01
ATC_suffixFD06
legal_AU
legal_BR
legal_CA
legal_DE
legal_NZ
legal_UK
legal_USRx-only
legal_US_comment
legal_UN
legal_status
CAS_number1350624-75-7
DrugBankDB14967
ChemSpiderIDNone
UNII_Ref
UNIIK911R84KEW
KEGGD10446
synonymsmargetuximab-cmkb, MGAH22
C6484H=10010N=1726O=2024S=42

| Drugs.com =

| elimination_half-life =

Margetuximab, sold under the brand name Margenza, is a chimeric IgG monoclonal antibody medication against HER2 used for the treatment of cancer.

The most common adverse drug reactions in combination with chemotherapy are fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, infusion-related reactions, palmar-plantar erythrodysesthesia, and extremity pain.

This drug was created by Raven biotechnologies, which was later acquired by MacroGenics. It was engineered to increase affinity for CD16A polymorphisms and decrease affinity for FcγRIIB (CD32B), an inhibitory receptor.

It binds to the same target (epitope) as trastuzumab, on the HER2 receptor.

Medical uses

Margetuximab is indicated, in combination with chemotherapy, for the treatment of adults 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.

History

It is in phase III clinical trials for combination therapy in metastatic breast cancer in collaboration with Merck. Phase II trials are also in progress for gastric cancer and esophageal cancer.

In June 2020, it received orphan drug designation from the U.S. Food and Drug Administration (FDA).

Efficacy was evaluated in SOPHIA (NCT02492711), a randomized, multicenter, open-label trial of 536 participants with IHC 3+ or ISH-amplified HER2+ metastatic breast cancer who had received prior treatment with other anti-HER2 therapies. Participants were randomized (1:1) to margetuximab plus chemotherapy or trastuzumab plus chemotherapy. Randomization was stratified by chemotherapy choice (capecitabine, eribulin, gemcitabine, or vinorelbine), number of lines of therapy in the metastatic setting (≤ 2, 2), and number of metastatic sites (≤ 2, 2). The trial was conducted at 166 sites in the United States and 16 other countries.

It was approved for medical use in the United States in December 2020.

References

References

  1. "Margenza FDA label".
  2. (16 December 2020). "FDA approves margetuximab for metastatic HER2-positive breast cancer".
  3. [http://www.ama-assn.org/resources/doc/usan/margetuximab.pdf Statement On A Nonproprietary Name Adopted By The USAN Council - Margetuximab], ''[[American Medical Association]]''.
  4. "Margenza". National Cancer Institute.
  5. "Pegram Discusses Promise of Margetuximab/Chemo Combo for HER2+ Breast Cancer. Jan 2017".
  6. (March 2021). "Margetuximab: First Approval". Drugs.
  7. {{ClinicalTrialsGov. NCT02492711
  8. "MacroGenics and Merck to Collaborate on Immuno-Oncology Study Evaluating Margetuximab in Combination with KEYTRUDA® (pembrolizumab) for Advanced Gastric Cancer". Merck & Co., Inc.
  9. {{ClinicalTrialsGov. NCT02689284
  10. (3 June 2020). "Margetuximab Orphan Drug Designations and Approvals".
  11. (16 December 2020). "Drug Trials Snapshot: Margenza".
  12. (May 2025). "Margenza: FDA-Approved Drugs".
Info: Wikipedia Source

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