POLATUZUMAB VEDOTIN
Polivy (polatuzumab vedotin) is an antibody drug conjugate pharmaceutical. Polatuzumab vedotin was first approved as Polivy on 2019-06-10. It is used to treat large b-cell lymphoma diffuse in the USA. It has been approved in Europe to treat b-cell lymphoma. The pharmaceutical is active against B-cell antigen receptor complex-associated protein beta chain.
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
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
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| polivy | Biologic Licensing Application | 2024-09-16 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
polatuzumab vedotin, Polivy, Genentech, Inc. | |||
| 2030-04-19 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9309 | Injection, polatuzumab vedotin-piiq, 1 mg |
Clinical
Clinical Trials
71 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 |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 23 | 44 | 8 | — | 3 | 63 |
| B-cell lymphoma | D016393 | — | — | 19 | 34 | 7 | — | 3 | 51 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 14 | 30 | 6 | — | 3 | 43 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 11 | 12 | 1 | — | 1 | 19 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Follicular lymphoma | D008224 | — | C82 | 7 | 11 | — | — | — | 12 |
| Recurrence | D012008 | — | — | 1 | 4 | — | — | — | 4 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 2 | 3 | — | — | — | 4 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | 3 | — | — | — | 4 |
| Mantle-cell lymphoma | D020522 | — | — | 1 | 4 | — | — | — | 4 |
| Hodgkin disease | D006689 | — | C81 | 1 | 3 | — | — | — | 3 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 1 | 2 | — | — | — | 2 |
| Aggression | D000374 | EFO_0003015 | — | 1 | 1 | — | — | — | 2 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | 1 | — | — | — | 2 |
| Burkitt lymphoma | D002051 | — | C83.7 | 1 | 1 | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
| Agranulocytosis | D000380 | HP_0012234 | D70 | — | — | — | — | 1 | 1 |
| Toxemia | D014115 | — | — | — | — | — | — | 1 | 1 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | POLATUZUMAB VEDOTIN |
| INN | polatuzumab vedotin |
| Description | Polatuzumab vedotin (humanized mab) |
| Classification | Antibody |
| Drug class | synthetic analogs of the dolastatin series; monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3301582 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12240 |
| UNII ID | KG6VO684Z6 (ChemIDplus, GSRS) |
Target
Agency Approved
CD79B
CD79B
Organism
Homo sapiens
Gene name
CD79B
Gene synonyms
B29, IGB
NCBI Gene ID
Protein name
B-cell antigen receptor complex-associated protein beta chain
Protein synonyms
B-cell-specific glycoprotein B29, CD79b, CD79b antigen (immunoglobulin-associated beta), CD79b molecule, immunoglobulin-associated beta, Ig-beta, Immunoglobulin-associated B29 protein
Uniprot ID
Mouse ortholog
Cd79b (15985)
B-cell antigen receptor complex-associated protein beta chain (P15530)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Polivy – Roche
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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 1,547 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,591 adverse events reported
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