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Title | Darzalex (Daratumumab) FDA Drug Label | ||||||||||||
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761036 | ||||||||||||
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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Daratumumab | Daratumumab | 0 | 25 |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Daratumumab | Darzalex | JNJ-54767414 | CD38 Antibody 20 | Darzalex (Daratumumab) is a human antibody against CD38 that induces antibody-dependent cell-mediated cytotoxicity and complement-mediated cytotoxicity against CD38-positive tumor cells (PMID: 30546360). Darzalex (Daratumumab) is FDA approved for multiple myeloma patients as a monotherapy or in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, or with bortezomib, melphalan, and prednisone, or with pomalidomide and dexamethasone, or with bortezomib, thalidomide and dexamethasone (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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