Besponsa(inotuzumab ozogamicin)
Besponsa (inotuzumab ozogamicin) is an antibody pharmaceutical. Inotuzumab ozogamicin was first approved as Besponsa on 2017-06-28. It is used to treat precursor cell lymphoblastic leukemia-lymphoma in the USA. It has been approved in Europe to treat precursor cell lymphoblastic leukemia-lymphoma. The pharmaceutical is active against B-cell receptor CD22.
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Commercial
Trade Name
FDA
EMA
Besponsa
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)
Inotuzumab ozogamicin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Besponsa | inotuzumab ozogamicin | Wyeth | N-761040 RX | 2017-08-17 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| besponsa | Biologic Licensing Application | 2020-09-15 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
inotuzumab ozogamicin, Besponsa, Wyeth Pharmaceuticals LLC | |||
| 2024-08-17 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9229 | Injection, inotuzumab ozogamicin, 0.1 mg |
Clinical
Clinical Trials
50 clinical trials
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | 7 | 2 | — | — | — | 8 | ||
| Philadelphia chromosome | D010677 | 2 | 3 | — | — | — | 4 | ||
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | 2 | 1 | — | — | — | 3 | ||
| Burkitt lymphoma | D002051 | C83.7 | 2 | 1 | — | — | — | 2 | |
| Lymphoma | D008223 | C85.9 | — | 2 | — | — | — | 2 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 1 | 2 | — | — | — | 2 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | 1 | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | INOTUZUMAB OZOGAMICIN |
| INN | inotuzumab ozogamicin |
| Description | Inotuzumab ozogamicin (humanized mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies; antibiotics (Micromonospora strains) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 635715-01-4 |
| RxCUI | 1942950 |
| ChEMBL ID | CHEMBL2108611 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB05889 |
| UNII ID | P93RUU11P7 (ChemIDplus, GSRS) |
Target
Agency Approved
CD22
CD22
Organism
Homo sapiens
Gene name
CD22
Gene synonyms
SIGLEC2
NCBI Gene ID
Protein name
B-cell receptor CD22
Protein synonyms
B-lymphocyte cell adhesion molecule, BL-CAM, CD22, CD22 antigen, Sialic acid-binding Ig-like lectin 2, Siglec-2, T-cell surface antigen Leu-14
Uniprot ID
Mouse ortholog
Cd22 (12483)
B-cell receptor CD22 (Q9WU51)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Besponsa - Pfizer
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,474 documents
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Safety
Black-box Warning
Black-box warning for: Besponsa
Adverse Events
Top Adverse Reactions
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778 adverse events reported
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