amivantamab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antitumor, monoclonal antibodies 5463 2171511-58-1

Description:

MoleculeDescription

Molfile

Synonyms:

  • amivantamab
  • amivantamab-vmjw
  • rybrevant
  • JNJ-6372
  • JNJ 61186372
  • CNTO4424
Amivantamab-vmjw is a bispecific antibody that binds to the extracellular domains of EGFR and MET. In in vitro and in vivo studies amivantamab-vmjw was able to disrupt EGFR and MET signaling functions through blocking ligand binding and, in exon 20 insertion mutation models, degradation of EGFR and MET. The presence of EGFR and MET on the surface of tumor cells also allows for targeting of these cells for destruction by immune effector cells, such as natural killer cells and macrophages, through antibody-dependent cellular cytotoxicity ( ADCC) and trogocytosis mechanisms, respectively.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
May 21, 2021 FDA JANSSEN BIOTECH
Sept. 12, 2021 EMA Janssen-Cilag International N.V.

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
Infusion related reaction 566.61 40.55 282 3039 416498 90208628
Paronychia 308.78 40.55 69 3252 7937 90617189
Dermatitis acneiform 219.08 40.55 50 3271 6304 90618822
Non-small cell lung cancer 209.08 40.55 45 3276 4336 90620790
Skin toxicity 148.59 40.55 37 3284 6742 90618384
Rash 110.64 40.55 140 3181 795960 89829166
Hypoalbuminaemia 96.93 40.55 32 3289 15865 90609261
Pulmonary embolism 91.82 40.55 58 3263 130762 90494364
Oxygen saturation decreased 73.75 40.55 47 3274 107436 90517690
Adverse reaction 67.39 40.55 29 3292 29683 90595443
Stasis dermatitis 57.92 40.55 12 3309 958 90624168
Febrile bone marrow aplasia 56.93 40.55 19 3302 9719 90615407
Mucosal inflammation 54.52 40.55 31 3290 57594 90567532
Flushing 51.66 40.55 35 3286 88456 90536670
Pancytopenia 48.45 40.55 38 3283 120225 90504901
Off label use 45.51 40.55 114 3207 1102138 89522988
Neutropenia 45.06 40.55 48 3273 224856 90400270
Peptic ulcer perforation 41.36 40.55 8 3313 450 90624676

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
Infusion related reaction 577.12 36.33 179 1774 60627 42558755
Paronychia 184.29 36.33 42 1911 4213 42615169
Dermatitis acneiform 168.97 36.33 44 1909 7695 42611687
Rash 138.33 36.33 108 1845 276846 42342536
Skin toxicity 72.91 36.33 22 1931 6527 42612855
Genital tract inflammation 41.12 36.33 6 1947 45 42619337
Rash pustular 40.86 36.33 14 1939 6201 42613181
Hypoalbuminaemia 40.85 36.33 18 1935 15592 42603790

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
Infusion related reaction 621.16 34.70 295 3865 380867 110204272
Dermatitis acneiform 362.00 34.70 86 4074 12609 110572530
Paronychia 320.75 34.70 76 4084 11005 110574134
Skin toxicity 172.90 34.70 47 4113 11736 110573403
Hypoalbuminaemia 116.33 34.70 43 4117 28931 110556208
Non-small cell lung cancer 104.11 34.70 29 4131 7906 110577233
Rash 103.94 34.70 140 4020 820824 109764315
Pulmonary embolism 81.19 34.70 66 4094 214408 110370731
Oxygen saturation decreased 62.95 34.70 50 4110 156932 110428207
Mucosal inflammation 62.34 34.70 41 4119 96100 110489039
Rash pustular 58.77 34.70 21 4139 12808 110572331
Febrile bone marrow aplasia 52.46 34.70 21 4139 17444 110567695
Stasis dermatitis 50.07 34.70 12 4148 1810 110583329
Flushing 45.50 34.70 35 4125 104701 110480438
Skin reaction 45.33 34.70 20 4140 21124 110564015
Skin disorder 45.18 34.70 25 4135 42888 110542251
Thrombocytopenia 44.58 34.70 60 4100 348825 110236314
Myelosuppression 42.02 34.70 32 4128 94308 110490831
Deep vein thrombosis 40.55 34.70 37 4123 139850 110445289
Off label use 39.94 34.70 135 4025 1500050 109085089
Pyogenic granuloma 39.79 34.70 8 4152 535 110584604
Pneumonitis 38.65 34.70 28 4132 76503 110508636
Embolism venous 38.02 34.70 12 4148 5011 110580128
Administration related reaction 37.69 34.70 7 4153 308 110584831
Neutropenia 36.97 34.70 57 4103 374563 110210576
Interstitial lung disease 36.81 34.70 35 4125 139299 110445840
Febrile neutropenia 36.73 34.70 52 4108 316715 110268424
Peptic ulcer perforation 36.38 34.70 8 4152 825 110584314
Adverse reaction 36.06 34.70 19 4141 29575 110555564
Genital tract inflammation 35.67 34.70 6 4154 148 110584991

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FX18 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates
MeSH PA D000074322 Antineoplastic Agents, Immunological
MeSH PA D000970 Antineoplastic Agents
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L01FX Other monoclonal antibodies and antibody drug conjugates 29 drugs
belantamab mafodotinblinatumomabbrentuximab vedotincatumaxomabdatopotamab deruxtecanelotuzumabelranatamabenfortumab vedotinepcoritamabgemtuzumab ozogamicinglofitamabipilimumab show all 29 →

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations indication 703228009




🐶 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
Epidermal growth factor receptor Kinase ANTIBODY BINDING Kd 8.84 DRUG LABEL DRUG LABEL
Hepatocyte growth factor receptor Kinase ANTIBODY BINDING Kd 10.40 DRUG LABEL DRUG LABEL

External reference:

IDSource
0JSR7Z0NB6 UNII
D11894 KEGG_DRUG
C5446297 UMLSCUI
CHEBI:757222 CHEBI
CHEMBL4297774 ChEMBL_ID
DB16695 DRUGBANK_ID
11030 INN_ID
C000718215 MESH_SUPPLEMENTAL_RECORD_UI
10505 IUPHAR_LIGAND_ID
1162751008 SNOMEDCT_US
1162897004 SNOMEDCT_US
4040533 VANDF
4040534 VANDF
346603 MMSL
39540 MMSL
d09748 MMSL
018739 NDDF
2549198 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Rybrevant HUMAN PRESCRIPTION DRUG LABEL 1 57894-501 INJECTION 350 mg INTRAVENOUS BLA 30 sections
Rybrevant HUMAN PRESCRIPTION DRUG LABEL 1 57894-501 INJECTION 350 mg INTRAVENOUS BLA 30 sections
Rybrevant Faspro HUMAN PRESCRIPTION DRUG LABEL 2 57894-510 INJECTION 1600 mg SUBCUTANEOUS BLA 29 sections
Rybrevant Faspro HUMAN PRESCRIPTION DRUG LABEL 2 57894-514 INJECTION 2240 mg SUBCUTANEOUS BLA 29 sections
Rybrevant Faspro HUMAN PRESCRIPTION DRUG LABEL 2 57894-515 INJECTION 2400 mg SUBCUTANEOUS BLA 29 sections
Rybrevant Faspro HUMAN PRESCRIPTION DRUG LABEL 2 57894-522 INJECTION 3520 mg SUBCUTANEOUS BLA 29 sections