Besponsa(inotuzumab ozogamicin)
Besponsa (inotuzumab ozogamicin) is an antibody drug conjugate 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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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
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| besponsa | Biologic Licensing Application | 2025-08-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| precursor cell lymphoblastic leukemia-lymphoma | — | D054198 | C91.0 |
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
67 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 6 | 27 | 5 | 2 | 5 | 41 |
| Precursor b-cell lymphoblastic leukemia-lymphoma | D015452 | — | — | 5 | 7 | 1 | 1 | 2 | 14 |
| Leukemia | D007938 | — | C95 | 1 | 6 | 2 | 1 | 2 | 12 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Burkitt lymphoma | D002051 | — | C83.7 | 4 | 7 | 2 | — | — | 12 |
| Lymphoma | D008223 | — | C85.9 | 3 | 5 | 2 | — | — | 9 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | 3 | 1 | — | 2 | 7 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 1 | 2 | — | — | 4 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 1 | 3 | 1 | — | — | 4 |
| Biphenotypic leukemia acute | D015456 | — | C95.0 | 1 | — | 1 | — | — | 2 |
| Central nervous system neoplasms | D016543 | — | — | — | — | 1 | — | — | 1 |
| Follicular lymphoma | D008224 | — | C82 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | — | — | 7 | 3 | — | — | — | 9 |
| Philadelphia chromosome | D010677 | — | — | 2 | 4 | — | — | — | 5 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 4 | 2 | — | — | — | 5 |
| Recurrence | D012008 | — | — | 3 | 2 | — | — | 1 | 5 |
| Hematologic neoplasms | D019337 | — | — | 1 | 1 | — | — | 1 | 2 |
| Hematopoietic stem cell transplantation | D018380 | — | — | 1 | 2 | — | — | — | 2 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | 1 | — | — | — | 1 |
| Blast crisis | D001752 | — | — | 1 | 1 | — | — | — | 1 |
| Hyperbilirubinemia | D006932 | — | — | — | 1 | — | — | — | 1 |
| Immunotherapy | D007167 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute disease | D000208 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 1 | 1 |
| Agranulocytosis | D000380 | HP_0012234 | D70 | — | — | — | — | 1 | 1 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
| Residual neoplasm | D018365 | — | — | — | — | — | — | 1 | 1 |
| Bone marrow transplantation | D016026 | — | — | — | — | — | — | 1 | 1 |
| Mycoses | D009181 | — | B35-B49 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
| Virus diseases | D014777 | — | B34 | — | — | — | — | 1 | 1 |
| Bacterial infections | D001424 | — | A49 | — | — | — | — | 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 | — |
| RxCUI | — |
| 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
No data
Financial
Revenue by drug
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â‚£
Besponsa – Pfizer
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,134 documents
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Safety
Black-box Warning
Black-box warning for: Besponsa
Adverse Events
Top Adverse Reactions
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2,464 adverse events reported
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