Linvoseltamab
Lynozyfic (linvoseltamab) is an antibody pharmaceutical. Linvoseltamab was first approved as Lynozyfic on 2025-07-02.
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Events Timeline
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Lynozyfic
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Linvoseltamab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Lynozyfic | linvoseltamab-gcpt | Regeneron Pharmaceuticals | N-761400 RX | 2025-07-02 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lynozyfic | Biologic Licensing Application | 2025-07-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple myeloma | — | D009101 | C90.0 |
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
17 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 | 6 | 9 | 2 | — | 1 | 13 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasma cell neoplasms | D054219 | — | — | 1 | 2 | — | — | 1 | 3 |
| Recurrence | D012008 | — | — | 2 | 2 | — | — | — | 2 |
| Smoldering multiple myeloma | D000075122 | — | — | — | 2 | — | — | — | 2 |
| Monoclonal gammopathy of undetermined significance | D008998 | EFO_1000836 | D47.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 1 | — | — | — | 1 | 2 |
| Food hypersensitivity | D005512 | EFO_1001890 | — | 1 | — | — | — | 1 | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Linvoseltamab |
| INN | linvoseltamab |
| Description | Linvoseltamab, sold under the brand name Lynozyfic, is an anti-cancer medication used for the treatment of people with relapsed or refractory multiple myeloma. Linvoseltamab is a bispecific monoclonal antibody that targets CD3 and B-cell maturation antigen (BCMA) (TNFRSF17). It is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager and a recombinant human immunoglobulin (Ig)G4 antibody.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL5095373 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB17447 |
| UNII ID | M3CPC50MZS (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
Black-box warning for: Lynozyfic
Adverse Events
0 adverse events reported
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