All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
antitumor, monoclonal antibodies	5463	2171511-58-1

Description:

Molecule

Description

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:

Date	Agency	Company	Orphan
May 21, 2021	FDA	JANSSEN BIOTECH
Sept. 12, 2021	EMA	Janssen-Cilag International N.V.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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

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

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN	ANTIBODY BINDING	Kd	8.84		DRUG LABEL	DRUG LABEL
Hepatocyte growth factor receptor	Kinase	P08581	MET_HUMAN	ANTIBODY BINDING	Kd	10.40		DRUG LABEL	DRUG LABEL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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