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| Stem definition | Drug id | CAS RN |
|---|---|---|
| rat origin | 5741 | 2408850-14-4 |
| Molecule | Description |
|---|---|
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Synonyms:
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Elranatamab-bcmm is a bispecific B-cell maturation antigen (BCMA)-directed T-cell engaging antibody that binds BCMA on plasma cells, plasmablasts, and multiple myeloma cells and CD3 on T-cells leading to cytolysis of the BCMA-expressing cells. Elranatamab-bcmm activated T-cells, caused proinflammatory cytokine release, and resulted in multiple myeloma cell lysis.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 14, 2023 | FDA | PFIZER INC |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 699.21 | 49.55 | 143 | 1215 | 27830 | 90599259 |
| Cytomegalovirus infection reactivation | 176.65 | 49.55 | 37 | 1321 | 7763 | 90619326 |
| Immune effector cell-associated neurotoxicity syndrome | 163.67 | 49.55 | 33 | 1325 | 5735 | 90621354 |
| Cytomegalovirus infection | 96.03 | 49.55 | 29 | 1329 | 26573 | 90600516 |
| Malignant neoplasm progression | 59.81 | 49.55 | 30 | 1328 | 106840 | 90520249 |
| Neutropenia | 55.44 | 49.55 | 37 | 1321 | 224867 | 90402222 |
| Hypogammaglobulinaemia | 53.36 | 49.55 | 15 | 1343 | 10659 | 90616430 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 518.06 | 33.75 | 145 | 1376 | 44382 | 42575432 |
| Immune effector cell-associated neurotoxicity syndrome | 161.50 | 33.75 | 42 | 1479 | 9419 | 42610395 |
| Cytomegalovirus infection reactivation | 95.97 | 33.75 | 29 | 1492 | 11149 | 42608665 |
| Cytomegalovirus infection | 72.49 | 33.75 | 31 | 1490 | 32275 | 42587539 |
| Malignant neoplasm progression | 57.74 | 33.75 | 40 | 1481 | 108360 | 42511454 |
| Hypogammaglobulinaemia | 53.77 | 33.75 | 19 | 1502 | 11872 | 42607942 |
| Infection | 47.45 | 33.75 | 36 | 1485 | 112032 | 42507782 |
| Neoplasm progression | 43.38 | 33.75 | 21 | 1500 | 28979 | 42590835 |
| Pyrexia | 43.31 | 33.75 | 61 | 1460 | 393981 | 42225833 |
| Second primary malignancy | 42.14 | 33.75 | 15 | 1506 | 9560 | 42610254 |
| COVID-19 | 39.93 | 33.75 | 33 | 1488 | 115915 | 42503899 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 1062.19 | 38.85 | 265 | 2672 | 70041 | 110516321 |
| Immune effector cell-associated neurotoxicity syndrome | 309.76 | 38.85 | 73 | 2864 | 14709 | 110571653 |
| Cytomegalovirus infection reactivation | 259.24 | 38.85 | 66 | 2871 | 18267 | 110568095 |
| Cytomegalovirus infection | 158.11 | 38.85 | 58 | 2879 | 54386 | 110531976 |
| Malignant neoplasm progression | 114.56 | 38.85 | 66 | 2871 | 174501 | 110411861 |
| Hypogammaglobulinaemia | 112.19 | 38.85 | 35 | 2902 | 20041 | 110566321 |
| Neoplasm progression | 72.45 | 38.85 | 35 | 2902 | 64560 | 110521802 |
| Pyrexia | 61.01 | 38.85 | 95 | 2842 | 898170 | 109688192 |
| Second primary malignancy | 58.91 | 38.85 | 21 | 2916 | 18047 | 110568315 |
| Cytomegalovirus viraemia | 51.75 | 38.85 | 19 | 2918 | 17745 | 110568617 |
| Pneumonia bacterial | 51.27 | 38.85 | 21 | 2916 | 26240 | 110560122 |
| Death | 48.84 | 38.85 | 75 | 2862 | 698794 | 109887568 |
| Neutropenia | 47.62 | 38.85 | 54 | 2883 | 374566 | 110211796 |
| COVID-19 | 43.04 | 38.85 | 42 | 2895 | 245018 | 110341344 |
| Cytomegalovirus chorioretinitis | 42.20 | 38.85 | 13 | 2924 | 7115 | 110579247 |
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| Source | Code | Description |
|---|---|---|
| ATC | L01FX32 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates |
| MeSH PA | D000074322 | Antineoplastic Agents, Immunological |
| MeSH PA | D000970 | Antineoplastic Agents |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Relapsed or refractory multiple myeloma | indication | 109989006 | DOID:9538 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Tumor necrosis factor receptor superfamily member 17 | Tumour-associated antigen | ANTIBODY BINDING | Kd | 10.42 | DRUG LABEL | DRUG LABEL | |||
| T-cell surface glycoprotein CD3 epsilon chain | Surface antigen | ANTIBODY BINDING | Kd | 7.77 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:757254 | CHEBI |
| CHEMBL4297809 | ChEMBL_ID |
| C000731940 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12889 | IUPHAR_LIGAND_ID |
| DB15395 | DRUGBANK_ID |
| 2054141000122109 | SNOMEDCT_US |
| 4042513 | VANDF |
| 4042514 | VANDF |
| C5667166 | UMLSCUI |
| 11838 | INN_ID |
| 370309 | MMSL |
| 41902 | MMSL |
| d10095 | MMSL |
| 019524 | NDDF |
| D12058 | KEGG_DRUG |
| L0HR9A577V | UNII |
| 2644880 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Elrexfio | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-2522 | INJECTION, SOLUTION | 44 mg | SUBCUTANEOUS | BLA | 30 sections |
| Elrexfio | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-4494 | INJECTION, SOLUTION | 76 mg | SUBCUTANEOUS | BLA | 30 sections |
| Elrexfio | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-252 | INJECTION, SOLUTION | 44 mg | SUBCUTANEOUS | BLA | 30 sections |