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

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

Stem definition	Drug id	CAS RN
human origin	5221	1537032-82-8

Description:

Molecule

Description

Synonyms: avelumab bavencio MSB0010718C MSB0010682

Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody. Avelumab is a human IgG1 lambda monoclonal antibody that has a molecular weight of approximately 147 kDa. PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production. Avelumab binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. Avelumab has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
57.10	mg	P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
Sept. 18, 2017	EMA	Merck Europe B.V.
Sept. 27, 2017	PMDA	Merck Serono Co., Ltd.
March 23, 2017	FDA	EMD SERONO INC

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
Disease progression	257.10	41.69	97	1448	156518	90470384
Neoplasm progression	85.08	41.69	31	1514	44455	90582447
Death	67.11	41.69	58	1487	456493	90170409
Hypothyroidism	46.05	41.69	21	1524	53106	90573796

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
Disease progression	384.94	30.84	216	4124	143440	42473555
Neoplasm progression	171.16	30.84	75	4265	28925	42588070
Death	131.85	30.84	197	4143	470988	42146007
Infusion related reaction	118.81	30.84	75	4265	60731	42556264
Interstitial lung disease	110.59	30.84	79	4261	78383	42538612
Chills	73.29	30.84	67	4273	93999	42522996
Skin toxicity	62.73	30.84	24	4316	6525	42610470
Hypothyroidism	58.65	30.84	38	4302	32046	42584949
Adrenal insufficiency	54.38	30.84	30	4310	18894	42598101
Myocarditis	54.36	30.84	30	4310	18908	42598087
General physical health deterioration	41.41	30.84	63	4277	151183	42465812
Myositis	41.15	30.84	23	4317	14843	42602152
Lymphoma transformation	37.08	30.84	9	4331	523	42616472
Transaminases increased	37.03	30.84	29	4311	32856	42584139
Dysphonia	36.23	30.84	27	4313	28423	42588572
Neuropathy peripheral	34.55	30.84	47	4293	101806	42515189
Polymyalgia rheumatica	31.49	30.84	11	4329	2312	42614683

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
Disease progression	617.35	32.44	285	5543	243749	110339722
Death	259.88	32.44	245	5583	698624	109884847
Neoplasm progression	249.04	32.44	102	5726	64493	110518978
Interstitial lung disease	146.01	32.44	91	5737	139243	110444228
Hypothyroidism	100.82	32.44	57	5771	72842	110510629
Infusion related reaction	81.15	32.44	100	5728	381062	110202409
Myocarditis	75.02	32.44	35	5793	30020	110553451
Myositis	67.79	32.44	33	5795	31083	110552388
Chills	66.69	32.44	65	5763	190515	110392956
Skin toxicity	64.38	32.44	24	5804	11759	110571712
Adrenal insufficiency	60.89	32.44	34	5794	42356	110541115
Palmar-plantar erythrodysaesthesia syndrome	53.79	32.44	31	5797	40994	110542477
Hepatic function abnormal	48.28	32.44	39	5789	89256	110494215
Neuropathy peripheral	48.01	32.44	53	5775	179224	110404247
Lymphoma transformation	47.54	32.44	10	5818	594	110582877
Immune-mediated hepatitis	45.37	32.44	16	5812	6695	110576776
Myasthenia gravis	44.42	32.44	22	5806	21489	110561982
Pneumonitis	42.59	32.44	34	5794	76497	110506974
Thyroiditis	41.89	32.44	15	5813	6558	110576913
Transaminases increased	41.47	32.44	31	5797	63359	110520112
General physical health deterioration	37.03	32.44	74	5754	425221	110158250
Immune-mediated myositis	35.26	32.44	13	5815	6173	110577298
Tumour hyperprogression	34.28	32.44	7	5821	359	110583112
Haematuria	34.14	32.44	31	5797	82974	110500497
Pyrexia	33.92	32.44	114	5714	898151	109685320
Dysphonia	32.49	32.44	29	5799	75900	110507571

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FF04	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors
MeSH PA	D000074322	Antineoplastic Agents, Immunological
MeSH PA	D000970	Antineoplastic Agents
FDA CS	M0001357	Antibodies, Monoclonal
FDA MoA	N0000193336	Programmed Death Ligand-1-directed Antibody Interactions
FDA MoA	N0000193337	Programmed Death Ligand-1 Antagonists
FDA EPC	N0000193338	Programmed Death Ligand-1 Blocker
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:233423	antifibrotic agent

Related Drugs by ATC class:

L01FF PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors 11 drugs

atezolizumabcemiplimabdostarlimabdurvalumabnivolumabpembrolizumabretifanlimabserplulimabsugemalimabtislelizumabtoripalimab

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

Disease	Relation	SNOMED_ID	DOID
Maintenance therapy of unresectable urothelial carcinoma in patients who have received chemotherapy	indication	27090000	DOID:2671
Merkel cell carcinoma	indication	253001006
Renal cell carcinoma	indication	702391001	DOID:4450

🐶 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
Programmed cell death 1 ligand 1	CD molecules	Q9NZQ7	PD1L1_HUMAN	ANTIBODY BINDING				UNKNOWN	DRUG LABEL

External reference:

ID	Source
KXG2PJ551I	UNII
4036553	VANDF
C4055417	UMLSCUI
CHEBI:755952	CHEBI
CHEMBL3833373	ChEMBL_ID
DB11945	DRUGBANK_ID
D10817	KEGG_DRUG
10062	INN_ID
C000609138	MESH_SUPPLEMENTAL_RECORD_UI
8735	IUPHAR_LIGAND_ID
733055009	SNOMEDCT_US
763506002	SNOMEDCT_US
254791	MMSL
32511	MMSL
d08537	MMSL
017142	NDDF
1875534	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BAVENCIO	HUMAN PRESCRIPTION DRUG LABEL	1	44087-3535	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	BLA	30 sections