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

Stem definitionDrug idCAS RN
humanized origin 5333 1313206-42-6

Description:

MoleculeDescription

Synonyms:

  • polatuzumab vedotin-piiq
  • polivy
  • CU-2711
  • RG-7596
  • RO-5541077
  • polatuzumab vedotin
  • RO-5541077-000
  • polatuzumab vedotin (genetical recombination)
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
Disease progression 942.50 45.98 344 4156 122414 63362108
Lymphoma 334.59 45.98 91 4409 12096 63472426
Blood lactate dehydrogenase increased 253.07 45.98 85 4415 23031 63461491
Neutrophil count decreased 191.96 45.98 89 4411 56317 63428205
Diffuse large B-cell lymphoma recurrent 180.11 45.98 40 4460 2280 63482242
Off label use 153.11 45.98 211 4289 674251 62810271
Febrile neutropenia 149.64 45.98 97 4403 118352 63366170
Neutropenia 134.80 45.98 106 4394 174899 63309623
Platelet count decreased 134.26 45.98 90 4410 116032 63368490
Diffuse large B-cell lymphoma refractory 133.79 45.98 28 4472 1202 63483320
Malignant neoplasm progression 117.95 45.98 73 4427 82048 63402474
Cytokine release syndrome 115.58 45.98 42 4458 14272 63470250
Pancytopenia 111.66 45.98 75 4425 96858 63387664
Lymphocyte count decreased 88.26 45.98 43 4457 30214 63454308
Thrombocytopenia 88.07 45.98 78 4422 151079 63333443
Cytomegalovirus infection reactivation 74.27 45.98 22 4478 3941 63480581
Cytopenia 71.69 45.98 28 4472 11573 63472949
White blood cell count decreased 71.61 45.98 67 4433 139037 63345485
Cytomegalovirus infection 70.93 45.98 33 4467 20919 63463603
COVID-19 67.07 45.98 59 4441 113044 63371478
Anaemia 58.79 45.98 87 4413 293343 63191179
Cytomegalovirus test positive 57.63 45.98 17 4483 3001 63481521
Tumour lysis syndrome 56.61 45.98 22 4478 8968 63475554
Myelosuppression 49.73 45.98 27 4473 23676 63460846

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
Disease progression 1085.60 44.43 478 5859 107599 34842995
Lymphoma 308.54 44.43 107 6230 12400 34938194
Off label use 258.60 44.43 345 5992 419179 34531415
Blood lactate dehydrogenase increased 248.54 44.43 108 6229 22882 34927712
Diffuse large B-cell lymphoma recurrent 214.05 44.43 59 6278 3169 34947425
COVID-19 211.14 44.43 146 6191 77404 34873190
Cytopenia 178.44 44.43 72 6265 12651 34937943
Neutrophil count decreased 152.63 44.43 102 6235 51002 34899592
Cytomegalovirus infection reactivation 146.48 44.43 49 6288 5069 34945525
Cytokine release syndrome 135.16 44.43 71 6266 22806 34927788
Malignant neoplasm progression 100.02 44.43 100 6237 87946 34862648
Neoplasm progression 98.40 44.43 58 6279 23242 34927352
Myelosuppression 94.83 44.43 53 6284 19212 34931382
Ill-defined disorder 78.78 44.43 42 6295 13867 34936727
Diffuse large B-cell lymphoma refractory 78.65 44.43 22 6315 1244 34949350
Platelet count decreased 76.51 44.43 101 6236 119616 34830978
Cytomegalovirus infection 75.10 44.43 51 6286 26084 34924510
Lymphocyte count decreased 67.03 44.43 45 6292 22577 34928017
Neutropenia 65.11 44.43 108 6229 156670 34793924
Infection 60.03 44.43 78 6259 90837 34859757
Febrile neutropenia 59.12 44.43 96 6241 136753 34813841
White blood cell count decreased 58.58 44.43 79 6258 95366 34855228
Lymphadenopathy 55.58 44.43 44 6293 28419 34922175
Disease recurrence 54.84 44.43 39 6298 21451 34929143
Hypogammaglobulinaemia 54.30 44.43 27 6310 7713 34942881
Neoplasm 50.35 44.43 23 6314 5444 34945150
Anaemia 44.78 44.43 117 6220 233218 34717376
Blood bilirubin decreased 44.68 44.43 11 6326 376 34950218
Aspartate aminotransferase increased 44.46 44.43 58 6279 67725 34882869

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
Disease progression 1226.66 39.23 533 8547 183829 79551479
Neutrophil count decreased 346.10 39.23 182 8898 93777 79641531
Blood lactate dehydrogenase increased 344.53 39.23 139 8941 39031 79696277
Diffuse large B-cell lymphoma recurrent 284.66 39.23 71 9009 4136 79731172
Off label use 279.50 39.23 421 8659 906794 78828514
Cytokine release syndrome 263.22 39.23 112 8968 35886 79699422
COVID-19 252.02 39.23 179 8901 157495 79577813
Lymphoma 247.93 39.23 88 8992 17372 79717936
Cytomegalovirus infection reactivation 233.45 39.23 71 9009 8645 79726663
Platelet count decreased 222.66 39.23 181 8899 194483 79540825
Cytopenia 220.15 39.23 84 8996 20299 79715009
Febrile neutropenia 199.65 39.23 183 8897 230816 79504492
Malignant neoplasm progression 167.11 39.23 132 8948 135858 79599450
Neutropenia 158.92 39.23 179 8901 287531 79447777
Diffuse large B-cell lymphoma refractory 158.46 39.23 36 9044 1399 79733909
Lymphocyte count decreased 158.03 39.23 86 8994 47203 79688105
Cytomegalovirus infection 157.81 39.23 83 8997 42561 79692747
Myelosuppression 142.22 39.23 76 9004 40220 79695088
White blood cell count decreased 137.42 39.23 136 8944 188152 79547156
Anaemia 114.21 39.23 191 8889 444824 79290484
Thrombocytopenia 97.95 39.23 135 8945 265124 79470184
Cytomegalovirus test positive 88.27 39.23 31 9049 5916 79729392
Hypogammaglobulinaemia 87.02 39.23 38 9042 12913 79722395
Neoplasm progression 78.46 39.23 57 9023 51625 79683683
Neoplasm 72.00 39.23 30 9050 9086 79726222
Lymphadenopathy 70.28 39.23 54 9026 53193 79682115
Tumour lysis syndrome 70.25 39.23 40 9040 23899 79711409
Neuropathy peripheral 64.62 39.23 80 9000 141225 79594083
Disease recurrence 56.60 39.23 44 9036 44065 79691243
Pyrexia 56.20 39.23 187 8893 678522 79056786
Immune effector cell-associated neurotoxicity syndrome 55.64 39.23 22 9058 5826 79729482
Cytomegalovirus enterocolitis 55.27 39.23 16 9064 1639 79733669
Arthralgia 53.09 39.23 3 9077 571800 79163508
Diffuse large B-cell lymphoma 51.69 39.23 26 9054 12123 79723185
Lymphoma transformation 45.88 39.23 10 9070 320 79734988
Haematotoxicity 45.71 39.23 26 9054 15493 79719815
Dizziness 45.29 39.23 4 9076 526437 79208871
Sepsis 44.43 39.23 96 8984 269332 79465976
Bacteraemia 42.66 39.23 33 9047 32791 79702517
Blood disorder 42.07 39.23 20 9060 8253 79727055
Pain 41.95 39.23 14 9066 703788 79031520
Headache 40.76 39.23 12 9068 653760 79081548

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 | Suggest Off label Use Form| |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
9714 INN_ID
8404 IUPHAR_LIGAND_ID
018025 NDDF
788328006 SNOMEDCT_US
788329003 SNOMEDCT_US
4038478 VANDF
4038479 VANDF
2174090 RXNORM
318099 MMSL
37058 MMSL
d09309 MMSL
C000600736 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
POLIVY HUMAN PRESCRIPTION DRUG LABEL 1 50242-103 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 30 mg INTRAVENOUS BLA 31 sections
POLIVY HUMAN PRESCRIPTION DRUG LABEL 1 50242-103 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 30 mg INTRAVENOUS BLA 31 sections
POLIVY HUMAN PRESCRIPTION DRUG LABEL 1 50242-103 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 30 mg INTRAVENOUS BLA 31 sections
POLIVY HUMAN PRESCRIPTION DRUG LABEL 1 50242-105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 140 mg INTRAVENOUS BLA 31 sections
POLIVY HUMAN PRESCRIPTION DRUG LABEL 1 50242-105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 140 mg INTRAVENOUS BLA 31 sections
POLIVY HUMAN PRESCRIPTION DRUG LABEL 1 50242-105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 140 mg INTRAVENOUS BLA 31 sections