polatuzumab vedotin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5333 1313206-42-6

Description:

MoleculeDescription

Synonyms:

  • polatuzumab vedotin-piiq
  • polivy
  • CU-2711
  • RG-7596
  • RO-5541077
  • polatuzumab vedotin
  • RO-5541077-000
Polatuzumab vedotin-piiq is a CD79b-directed antibody-drug conjugate with activity against dividing B cells. The small molecule, MMAE is an anti-mitotic agent covalently attached to the antibody via a cleavable linker. The monoclonal antibody binds to CD79b, a B-cell specific surface protein, which is a component of the B-cell receptor. Upon binding CD79b, polatuzumab vedotin-piiq is internalized, and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
April 16, 2018 EMA ROCHE REGISTRATION LIMITED, UK
June 10, 2019 FDA GENENTECH
March 23, 2021 PMDA Chugai Pharmaceutical Co., Ltd

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Diffuse large B-cell lymphoma recurrent 181.06 43.45 34 1918 1561 50601611
Diffuse large B-cell lymphoma refractory 135.93 43.45 25 1927 1021 50602151
Febrile neutropenia 105.11 43.45 58 1894 97609 50505563
Thrombocytopenia 76.06 43.45 52 1900 127621 50475551
Disease progression 64.13 43.45 42 1910 95824 50507348
Pancytopenia 61.59 43.45 39 1913 83991 50519181
Neutropenia 58.24 43.45 47 1905 147918 50455254
Neutrophil count decreased 51.18 43.45 28 1924 45998 50557174

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Diffuse large B-cell lymphoma recurrent 192.30 46.46 45 2618 2552 29569312
Disease progression 111.91 46.46 77 2586 81839 29490025
Diffuse large B-cell lymphoma refractory 78.97 46.46 18 2645 904 29570960
Myelosuppression 70.41 46.46 30 2633 12197 29559667
Ill-defined disorder 68.39 46.46 29 2634 11649 29560215
Cytopenia 62.81 46.46 26 2637 9833 29562031
Blood lactate dehydrogenase increased 60.36 46.46 31 2632 19178 29552686
Off label use 57.39 46.46 99 2564 300701 29271163
Product use in unapproved indication 56.61 46.46 53 2610 86822 29485042
Aspartate aminotransferase increased 54.14 46.46 44 2619 59681 29512183
Neutrophil count decreased 52.43 46.46 38 2625 43529 29528335
Neutropenia 47.94 46.46 59 2604 131652 29440212

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Diffuse large B-cell lymphoma recurrent 294.86 43.45 61 3641 3085 64491945
Diffuse large B-cell lymphoma refractory 166.81 43.45 32 3670 1092 64493938
Disease progression 142.74 43.45 93 3609 141587 64353443
Febrile neutropenia 123.56 43.45 95 3607 187562 64307468
Myelosuppression 100.00 43.45 41 3661 23789 64471241
Neutrophil count decreased 98.58 43.45 59 3643 77137 64417893
Cytomegalovirus infection reactivation 92.32 43.45 27 3675 5729 64489301
Platelet count decreased 87.12 43.45 74 3628 167637 64327393
Product use in unapproved indication 85.81 43.45 75 3627 176543 64318487
Neutropenia 80.60 43.45 83 3619 239541 64255489
Cytopenia 80.15 43.45 31 3671 15440 64479590
Thrombocytopenia 79.78 43.45 80 3622 223721 64271309
Blood lactate dehydrogenase increased 77.94 43.45 38 3664 33040 64461990
Off label use 66.89 43.45 125 3577 632681 63862349
Cytokine release syndrome 64.77 43.45 29 3673 20800 64474230
Lymphocyte count decreased 54.21 43.45 32 3670 40667 64454363
Cytomegalovirus infection 54.19 43.45 31 3671 37168 64457862
Neuropathy peripheral 53.17 43.45 48 3654 117477 64377553
Anaemia 50.46 43.45 83 3619 378597 64116433
White blood cell count decreased 46.43 43.45 51 3651 157786 64337244

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FX14 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diffuse large B-cell lymphoma refractory indication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Tubulin beta Tumour-associated antigen BINDING AGENT UNKNOWN DRUG LABEL
B-cell antigen receptor complex-associated protein beta chain Tumour-associated antigen ANTIBODY BINDING UNKNOWN DRUG LABEL

External reference:

IDSource
KG6VO684Z6 UNII
C4078806 UMLSCUI
CHEMBL3301582 ChEMBL_ID
DB12240 DRUGBANK_ID
D10761 KEGG_DRUG
8404 IUPHAR_LIGAND_ID
2174090 RXNORM
318099 MMSL
37058 MMSL
d09309 MMSL
788328006 SNOMEDCT_US
788329003 SNOMEDCT_US
4038478 VANDF
4038479 VANDF
018025 NDDF
C000600736 MESH_SUPPLEMENTAL_RECORD_UI
9714 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
POLIVY HUMAN PRESCRIPTION DRUG LABEL 1 50242-103 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 30 mg INTRAVENOUS BLA 29 sections
POLIVY HUMAN PRESCRIPTION DRUG LABEL 1 50242-103 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 30 mg INTRAVENOUS BLA 29 sections
POLIVY HUMAN PRESCRIPTION DRUG LABEL 1 50242-105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 140 mg INTRAVENOUS BLA 29 sections
POLIVY HUMAN PRESCRIPTION DRUG LABEL 1 50242-105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 140 mg INTRAVENOUS BLA 29 sections