|Other names||margetuximab-cmkb, MGAH22|
|Drug class||HER2/neu receptor antagonist|
|Main uses||Breast cancer that is HER2-positive|
|Side effects||Tiredness, nausea, diarrhea, headache, fever, hair loss, abdominal pain, peripheral neuropathy, muscle pain, shortness of breath, infusion-related reactions|
|Typical dose||15 mg/kg|
|Chemical and physical data|
|Molar mass||145873.98 g·mol−1|
Margetuximab, sold under the brand name Margenza, is a medication used to treat metastatic breast cancer that is HER2-positive. It is used in people who have failed prior treatments. It is given by gradual injection into a vein.
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. Use in pregnancy may harm the baby. It is a IgG monoclonal antibody that binds to the human epidermal growth factor receptor 2 (HER2).
Margetuximab was approved for medical use in the United States in 2020. It is not approved in Europe or the United Kingdom as of 2022. In the United States it costs about $9,100 every three weeks for someone who weights 70 kg.
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.
It is given at a dose of 15 mg/kg every three weeks.
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.[needs update]
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.
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