Carvykti(ciltacabtagene autoleucel)
Carvykti (ciltacabtagene autoleucel) is a gene pharmaceutical. Ciltacabtagene autoleucel was first approved as Carvykti on 2022-02-28. It is used to treat multiple myeloma in the USA. It has been approved in Europe to treat multiple myeloma.
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Commercial
Therapeutic Areas
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Carvykti
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)
Ciltacabtagene autoleucel
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Carvykti | ciltacabtagene autoleucel | Johnson & Johnson | N-125746 RX | 2022-02-28 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| carvykti | 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 | ||
|---|---|---|---|
ciltacabtagene autoleucel, Carvykti, Janssen Biotech, Inc. | |||
| 2034-02-28 | Reference product excl. | ||
| 2029-02-28 | Orphan excl. | ||
Patent Expiration
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HCPCS
Code | Description |
|---|---|
| Q2056 | Ciltacabtagene autoleucel, up to 100 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 4 | 10 | 3 | 1 | 3 | 19 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasma cell neoplasms | D054219 | — | — | 4 | 10 | 3 | — | 2 | 17 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Smoldering multiple myeloma | D000075122 | — | — | — | 2 | — | — | — | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cytokine release syndrome | D000080424 | — | D89.83 | — | — | — | — | 1 | 1 |
| Follicular lymphoma | D008224 | — | C82 | — | — | — | — | 1 | 1 |
| Myocarditis | D009205 | — | I51.4 | — | — | — | — | 1 | 1 |
| Adoptive immunotherapy | D016219 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ciltacabtagene autoleucel |
| INN | ciltacabtagene autoleucel |
| Description | Ciltacabtagene autoleucel, sold under the brand name Carvykti, is an anti-cancer medication used to treat multiple myeloma. Ciltacabtagene autoleucel is a BCMA (B-cell maturation antigen)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. Each dose is customized using the recipient's own T-cells, which are collected and genetically modified, and infused back into the recipient.
|
| Classification | Gene |
| Drug class | Antineoplastic |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4802263 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16738 |
| UNII ID | 0L1F17908Q (ChemIDplus, GSRS) |
Target
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Carvykti – Johnson & Johnson
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Additional graphs summarizing 968 documents
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Safety
Black-box Warning
Black-box warning for: Carvykti
Adverse Events
Top Adverse Reactions
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1,141 adverse events reported
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