avelumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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

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:

None

ADMET properties:

None

Approvals:

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

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FDA Adverse Event Reporting System (Female)

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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	141.31	43.91	60	1092	122698	63365172
Neoplasm progression	81.67	43.91	29	1123	36399	63451471

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FDA Adverse Event Reporting System (Male)

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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	175.28	28.07	112	2969	107965	34845885
Neoplasm progression	172.76	28.07	68	3013	23232	34930618
Infusion related reaction	122.07	28.07	69	3012	52988	34900862
Chills	71.04	28.07	58	3023	80985	34872865
Death	62.60	28.07	119	2962	397930	34555920
Skin toxicity	61.56	28.07	21	3060	4763	34949087
Hypothyroidism	52.90	28.07	29	3052	20873	34932977
Adrenal insufficiency	51.46	28.07	25	3056	14022	34939828
Interstitial lung disease	45.47	28.07	41	3040	65241	34888609
General physical health deterioration	42.04	28.07	54	3027	128215	34825635

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FDA Adverse Event Reporting System (Geriatric)

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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	267.38	29.33	148	4046	184214	79555980
Neoplasm progression	242.80	29.33	94	4100	51588	79688606
Death	120.72	29.33	148	4046	566366	79173828
Infusion related reaction	85.62	29.33	81	4113	230156	79510038
Hypothyroidism	78.10	29.33	43	4151	52349	79687845
Interstitial lung disease	62.82	29.33	50	4144	112550	79627644
Adrenal insufficiency	58.52	29.33	29	4165	28458	79711736
Palmar-plantar erythrodysaesthesia syndrome	57.21	29.33	30	4164	33104	79707090
Skin toxicity	56.94	29.33	20	4174	8294	79731900
Myocarditis	56.45	29.33	26	4168	21707	79718487

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

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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

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🐶 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:

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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

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External reference:

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ID	Source
017142	NDDF
10062	INN_ID
1875534	RXNORM
254791	MMSL
32511	MMSL
4036553	VANDF
733055009	SNOMEDCT_US
763506002	SNOMEDCT_US
8735	IUPHAR_LIGAND_ID
C000609138	MESH_SUPPLEMENTAL_RECORD_UI

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Pharmaceutical products:

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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
BAVENCIO	HUMAN PRESCRIPTION DRUG LABEL	1	44087-3535	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	BLA	30 sections
BAVENCIO	HUMAN PRESCRIPTION DRUG LABEL	1	44087-3535	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	BLA	30 sections

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