Polivy(polatuzumab vedotin)
Polivy (polatuzumab vedotin) is an antibody 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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Commercial
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)
Polatuzumab vedotin
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Polivy | polatuzumab vedotin-piiq | Genentech | N-761121 RX | 2019-06-10 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
polivy | Biologic Licensing Application | 2020-09-30 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
polatuzumab vedotin, Polivy, Genentech, Inc. | |||
2026-06-10 | Orphan excl. |
Patent Expiration
No data
HCPCS
Code | Description |
---|---|
J9309 | Injection, polatuzumab vedotin-piiq, 1 mg |
Clinical
Clinical Trials
42 clinical trials
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Indications Phases 4
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
B-cell lymphoma | D016393 | 5 | 6 | — | — | — | 9 | ||
Follicular lymphoma | D008224 | C82 | 3 | 6 | — | — | — | 7 | |
B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | 2 | — | — | — | 3 | |
Mantle-cell lymphoma | D020522 | C83.1 | 1 | 3 | — | — | — | 3 | |
Lymphoma | D008223 | C85.9 | 2 | 2 | — | — | — | 2 | |
Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 1 | 2 | — | — | — | 2 |
Hodgkin disease | D006689 | C81 | 1 | 2 | — | — | — | 2 | |
Burkitt lymphoma | D002051 | C83.7 | 1 | 1 | — | — | — | 1 | |
B-cell lymphoma marginal zone | D018442 | C88.4 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Recurrence | D012008 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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 | 1313206-42-6 |
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
Clinical Variant
No data
Financial
Polivy - Roche
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,097 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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505 adverse events reported
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