Talvey(talquetamab)
Talvey (talquetamab) is an antibody pharmaceutical. Talquetamab was first approved as Talvey on 2023-08-09. It is used to treat multiple myeloma in the USA. It has been approved in Europe to treat multiple myeloma. It is known to target G-protein coupled receptor family C group 5 member D.
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Talvey
Drug Products
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Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
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Biosimilar product - 351(k)
Biosimilar product - 351(k)
Talquetamab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Talvey | talquetamab-tgvs | Johnson & Johnson | N-761342 RX | 2023-08-09 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| talvey | Biologic Licensing Application | 2024-07-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple myeloma | — | D009101 | C90.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
talquetamab, Talvey, Janssen Biotech, Inc. | |||
| 2030-08-09 | Orphan excl. | ||
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Clinical
Clinical Trials
28 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 8 | 15 | 4 | — | 3 | 28 |
| Plasma cell neoplasms | D054219 | — | — | 7 | 15 | 4 | — | 3 | 27 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | 1 | 1 | — | — | — | 2 |
| Smoldering multiple myeloma | D000075122 | — | — | — | 1 | — | — | — | 1 |
| Residual neoplasm | D018365 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Talquetamab |
| INN | talquetamab |
| Description | Talquetamab, sold under the brand name Talvey, is a humanized monoclonal antibody used for the treatment of multiple myeloma. It is a bispecific GPRC5D-directed CD3 T-cell engager. Talquetamab is a bispecific antibody against two targets: human CD3, a T-cell surface antigen, and human G-protein coupled receptor family C group 5 member D (GPRC5D), a tumor-associated antigen with potential antineoplastic activity. Talquetamab binds both targets, drawing the T cells close to the tumor cells, causing a cytotoxic T-lymphocyte response. It is being developed by Janssen Pharmaceuticals.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 2226212-40-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594503 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16678 |
| UNII ID | 4W3KFI3TN3 (ChemIDplus, GSRS) |
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Safety
Black-box Warning
Black-box warning for: Talvey
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343 adverse events reported
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