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Title | Blincyto (blinatumomab) FDA Drug Label | ||||||||||||
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125557 | ||||||||||||
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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Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Blinatumomab | Blincyto | anti-CD19/anti-CD3 recombinant bispecific|monoclonal antibody MT103|MEDI-538 | CD19 Antibody 20 | Blincyto (blinatumomab) is a bispecific antibody that binds both CD19 on B-cells and the CD3 complex on T-cells, therefore facilitates T-cell mediated killing of CD19-expressing tumor cells (PMID: 26337639). Blincyto (blinatumomab) is FDA approved for the treatment of B-cell precursor acute lymphoblastic leukemia in adult and children negative for BCR-ABL1 (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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