Polivy(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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Events
FDA approval date
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Patent expiration date
Study first post date
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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
Polivy
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 |
|---|---|---|
| polivy | Biologic Licensing Application | 2024-09-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| large b-cell lymphoma diffuse | — | D016403 | C83.3 |
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
No data
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 (INN; brand name Polivy, is an antibody-drug conjugate or ADC designed for the treatment of cancer. The US Food and Drug Administration approved polatuzumab vedotin in June 2019 for treatment of diffuse large B-cell lymphoma when used in combination with bendamustine and rituximab. The drug was developed by Genentech and Roche.[not verified in body]
|
| 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 1,540 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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