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| Stem definition | Drug id | CAS RN |
|---|---|---|
| rat origin | 5742 | 2226212-40-2 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Talquetamab-tgvs is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as healthy tissues such as epithelial cells in keratinized tissues of the skin and tongue. In vitro, talquetamab-tgvs activated T-cells caused the release of proinflammatory cytokines and resulted in the lysis of multiple myeloma cells. Talquetamab-tgvs had anti-tumor activity in mouse models of multiple myeloma.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 9, 2023 | FDA | JANSSEN BIOTECH | |
| Aug. 21, 2023 | EMA | JANSSEN-CILAG INTERNATIONAL N.V. |
| 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 | 435.28 | 55.53 | 87 | 655 | 27886 | 90599819 |
| Immune effector cell-associated neurotoxicity syndrome | 210.54 | 55.53 | 37 | 705 | 5731 | 90621974 |
| Dysgeusia | 107.00 | 55.53 | 32 | 710 | 52528 | 90575177 |
| Skin exfoliation | 59.79 | 55.53 | 22 | 720 | 67891 | 90559814 |
| 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 | 390.04 | 50.96 | 107 | 940 | 44420 | 42575868 |
| Immune effector cell-associated neurotoxicity syndrome | 131.29 | 50.96 | 33 | 1014 | 9428 | 42610860 |
| Dysgeusia | 116.12 | 50.96 | 40 | 1007 | 34149 | 42586139 |
| Skin exfoliation | 90.30 | 50.96 | 35 | 1012 | 41518 | 42578770 |
| Onychomadesis | 66.49 | 50.96 | 12 | 1035 | 698 | 42619590 |
| Nail dystrophy | 58.78 | 50.96 | 10 | 1037 | 412 | 42619876 |
| 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 | 606.00 | 43.16 | 148 | 1362 | 70158 | 110517631 |
| Immune effector cell-associated neurotoxicity syndrome | 204.64 | 43.16 | 46 | 1464 | 14736 | 110573053 |
| Dysgeusia | 145.65 | 43.16 | 49 | 1461 | 69936 | 110517853 |
| Skin exfoliation | 88.14 | 43.16 | 36 | 1474 | 87615 | 110500174 |
| Nail dystrophy | 66.94 | 43.16 | 12 | 1498 | 1216 | 110586573 |
| Plasma cell myeloma | 56.95 | 43.16 | 24 | 1486 | 62912 | 110524877 |
| Ageusia | 45.70 | 43.16 | 15 | 1495 | 19630 | 110568159 |
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| Source | Code | Description |
|---|---|---|
| ATC | L01FX29 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| T-cell surface glycoprotein CD3 | Surface antigen | ANTIBODY BINDING | EC50 | 7.82 | DRUG LABEL | DRUG LABEL | |||
| G-protein coupled receptor family C group 5 member D | GPCR | ANTIBODY BINDING | EC50 | 6.72 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:757979 | CHEBI |
| CHEMBL4594503 | ChEMBL_ID |
| C000730985 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12240 | IUPHAR_LIGAND_ID |
| DB16678 | DRUGBANK_ID |
| 1363065009 | SNOMEDCT_US |
| 4042504 | VANDF |
| 4042505 | VANDF |
| C5419330 | UMLSCUI |
| 11173 | INN_ID |
| 370272 | MMSL |
| 41893 | MMSL |
| d10092 | MMSL |
| 019517 | NDDF |
| D12180 | KEGG_DRUG |
| 4W3KFI3TN3 | UNII |
| 2644447 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TALVEY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-469 | INJECTION | 3 mg | SUBCUTANEOUS | BLA | 31 sections |
| TALVEY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-469 | INJECTION | 3 mg | SUBCUTANEOUS | BLA | 31 sections |
| TALVEY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-470 | INJECTION | 40 mg | SUBCUTANEOUS | BLA | 31 sections |
| TALVEY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-470 | INJECTION | 40 mg | SUBCUTANEOUS | BLA | 31 sections |