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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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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
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
Polivypolatuzumab vedotin-piiqGenentechN-761121 RX2019-06-10
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
polivyBiologic Licensing Application2020-09-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
large b-cell lymphoma diffuse—D016403C83.3
Agency Specific
FDA
EMA
Expiration
Code
polatuzumab vedotin, Polivy, Genentech, Inc.
2026-06-10Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FX: Other monoclonal antibodies and antibody drug conjugates in atc
— L01FX14: Polatuzumab vedotin
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 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Large b-cell lymphoma diffuseD016403C83.38114—119
Non-hodgkin lymphomaD008228C85.9871——12
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphomaD01639356———9
Follicular lymphomaD008224C8236———7
B-cell chronic lymphocytic leukemiaD015451C91.112———3
Mantle-cell lymphomaD020522C83.113———3
LymphomaD008223C85.922———2
Reactive arthritisD016918EFO_0007460M02.312———2
Hodgkin diseaseD006689C8112———2
Burkitt lymphomaD002051C83.711———1
B-cell lymphoma marginal zoneD018442C88.4—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD0120081————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePOLATUZUMAB VEDOTIN
INNpolatuzumab 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 classsynthetic analogs of the dolastatin series; monoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1313206-42-6
RxCUI—
ChEMBL IDCHEMBL3301582
ChEBI ID—
PubChem CID—
DrugBankDB12240
UNII IDKG6VO684Z6 (ChemIDplus, GSRS)
Target
Agency Approved
CD79B
CD79B
Organism
Homo sapiens
Gene name
CD79B
Gene synonyms
B29, IGB
NCBI Gene ID
974
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
Q9BU06
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
Mock data
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505 adverse events reported
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