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Title | Margenza (margetuximab-cmkb) FDA Drug Label | ||||||||||||
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761150 | ||||||||||||
Abstract Text |
Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Margetuximab-cmkb | Margetuximab-cmkb | 0 | 3 |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Margetuximab-cmkb | Margenza | MGAH22|MGAH-22 | HER2 (ERBB2) Antibody 72 | Margenza (margetuximab-cmkb) is a monoclonal antibody that binds ERBB2 (HER2) and induces antitumor response against ERBB2 (HER2)-expressing tumor cells (PMID: 22129105, PMID: 32653053). Margenza (margetuximab-cmkb) in combination with chemotherapy is FDA approved for use in patients with metastatic ERBB2 (HER2)-positive breast cancer who had received two or more prior anti-ERBB2 (HER2) therapies (FDA.gov). |
Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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