Margetuximab

Margetuximab
Monoclonal antibody
Type?
SourceChimeric (mouse/human)
TargetHER2
Names
Trade namesMargenza
Other namesmargetuximab-cmkb, MGAH22
Clinical data
Drug classHER2/neu receptor antagonist
Main usesBreast cancer that is HER2-positive[1]
Side effectsTiredness, nausea, diarrhea, headache, fever, hair loss, abdominal pain, peripheral neuropathy, muscle pain, shortness of breath, infusion-related reactions[1]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Pregnancy
category
  • Not recommended. Margetuximab can cause fetal harm when administered to a pregnant woman.[2]
Routes of
use		Intravenous
Typical dose15 mg/kg[1]
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
Chemical and physical data
FormulaC6484H10010N1726O2024S42
Molar mass145873.98 g·mol−1

Margetuximab, sold under the brand name Margenza, is a medication used to treat metastatic breast cancer that is HER2-positive.[1] It is used in people who have failed prior treatments.[1] It is given by gradual injection into a vein.[1]

Common side effects, when used in combination with chemotherapy, include tiredness, nausea, diarrhea, headache, fever, hair loss, abdominal pain, peripheral neuropathy, muscle pain, shortness of breath, and infusion-related reactions.[1] Use in pregnancy may harm the baby.[1] It is a IgG monoclonal antibody that binds to the human epidermal growth factor receptor 2 (HER2).[4]

Margetuximab was approved for medical use in the United States in 2020.[1] It is not approved in Europe or the United Kingdom as of 2022.[5] In the United States it costs about $9,100 every three weeks for someone who weights 70 kg.[6]

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.[2][3][7]

Dosage

It is given at a dose of 15 mg/kg every three weeks.[1]

History

It is in phase III clinical trials for combination therapy in metastatic breast cancer[8] in collaboration with Merck.[9] Phase II trials are also in progress for gastric cancer and esophageal cancer.[10]

In June 2020, it received orphan drug designation from the U.S. Food and Drug Administration (FDA).[11]

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.[3][12] Participants were randomized (1:1) to margetuximab plus chemotherapy or trastuzumab plus chemotherapy.[3] 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).[3] The trial was conducted at 166 sites in the United States and 16 other countries.[12]

It was approved for medical use in the United States in December 2020.[3][13][12] This drug was created by Raven biotechnologies, which was later acquired by MacroGenics.

References

  1. 1 2 3 4 5 6 7 8 9 10 "DailyMed - MARGENZA- margetuximab-cmkb injection, solution, concentrate". dailymed.nlm.nih.gov. Archived from the original on 17 January 2022. Retrieved 2 November 2022.
  2. 1 2 3 "Margenza FDA label" (PDF). Archived (PDF) from the original on 2021-11-02. Retrieved 2022-02-17.
  3. 1 2 3 4 5 6 "FDA approves margetuximab for metastatic HER2-positive breast cancer". U.S. Food and Drug Administration (FDA). 16 December 2020. Archived from the original on 23 December 2020. Retrieved 25 December 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ↑ "Margenza". NCI Drug Dictionary. National Cancer Institute. Archived from the original on 15 December 2021. Retrieved 17 December 2020.
  5. ↑ "Margetuximab". SPS - Specialist Pharmacy Service. 30 September 2016. Archived from the original on 23 January 2022. Retrieved 2 November 2022.
  6. ↑ "Margenza Prices, Coupons, Copay & Patient Assistance". Drugs.com. Retrieved 2 November 2022.
  7. ↑ Markham A (March 2021). "Margetuximab: First Approval". Drugs. 81 (5): 599–604. doi:10.1007/s40265-021-01485-2. PMID 33761116. S2CID 232329257.
  8. ↑ Clinical trial number NCT02492711 at ClinicalTrials.gov
  9. ↑ "MacroGenics and Merck to Collaborate on Immuno-Oncology Study Evaluating Margetuximab in Combination with KEYTRUDA® (pembrolizumab) for Advanced Gastric Cancer". Merck & Co., Inc. Archived from the original on 10 May 2017.
  10. ↑ Clinical trial number NCT02689284 at ClinicalTrials.gov
  11. ↑ "Margetuximab Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 3 June 2020. Archived from the original on 7 June 2020. Retrieved 6 June 2020.
  12. 1 2 3 "Drug Trials Snapshot: Margenza". U.S. Food and Drug Administration (FDA). 16 December 2020. Archived from the original on 7 January 2021. Retrieved 6 January 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  13. ↑ "Margenza: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 23 March 2021. Retrieved 17 December 2020.
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