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

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

Stem definition	Drug id	CAS RN
humanized origin	5333	1313206-42-6

Description:

Molecule

Description

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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
March 23, 2021	PMDA	Chugai Pharmaceutical Co., Ltd
June 10, 2019	FDA	GENENTECH
April 16, 2018	EMA	ROCHE REGISTRATION LIMITED, UK

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	1606.02	43.00	582	7739	156033	90464093
Diffuse large B-cell lymphoma recurrent	434.26	43.00	93	8228	3433	90616693
Blood lactate dehydrogenase increased	417.60	43.00	136	8185	25796	90594330
Neutrophil count decreased	384.77	43.00	168	8153	71364	90548762
Lymphoma	375.69	43.00	108	8213	13483	90606643
Neutropenia	269.87	43.00	197	8124	224707	90395419
Febrile neutropenia	264.03	43.00	170	8151	158179	90461947
Cytokine release syndrome	258.36	43.00	97	8224	27876	90592250
Platelet count decreased	248.11	43.00	155	8166	136814	90483312
Myelosuppression	221.88	43.00	105	8216	53486	90566640
Lymphocyte count decreased	213.46	43.00	90	8231	34960	90585166
White blood cell count decreased	213.04	43.00	152	8169	166957	90453169
Off label use	206.07	43.00	363	7958	1101889	89518237
Diffuse large B-cell lymphoma refractory	163.46	43.00	37	8284	1763	90618363
Anaemia	160.69	43.00	179	8142	352623	90267503
COVID-19	160.61	43.00	129	8192	168714	90451412
Thrombocytopenia	129.25	43.00	125	8196	208600	90411526
Cytopenia	127.24	43.00	51	8270	17398	90602728
Neuropathy peripheral	116.23	43.00	98	8223	136872	90483254
Malignant neoplasm progression	110.84	43.00	86	8235	106784	90513342
Pancytopenia	106.06	43.00	88	8233	120175	90499951
Tumour lysis syndrome	96.83	43.00	37	8284	11115	90609011
Cytomegalovirus infection	94.55	43.00	47	8274	26555	90593571
Death	77.51	43.00	145	8176	456406	90163720
Cytomegalovirus infection reactivation	71.76	43.00	27	8294	7773	90612353
Hypoalbuminaemia	68.32	43.00	32	8289	15865	90604261
Arthralgia	59.25	43.00	3	8318	778519	89841607
Neutropenic infection	57.27	43.00	16	8305	1793	90618333
Pyrexia	54.52	43.00	158	8163	660327	89959799
Cytomegalovirus test positive	50.37	43.00	17	8304	3574	90616552
Leukopenia	48.90	43.00	53	8268	100657	90519469
Headache	48.81	43.00	10	8311	862736	89757390
Neoplasm progression	48.69	43.00	37	8284	44449	90575677
Hypokalaemia	48.55	43.00	60	8261	131056	90489070
Haematotoxicity	47.06	43.00	23	8298	12512	90607614
Immune effector cell-associated neurotoxicity syndrome	46.02	43.00	18	8303	5750	90614376
Lymphoma transformation	45.60	43.00	9	8312	219	90619907

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	1893.29	35.34	871	10846	142785	42466833
Blood lactate dehydrogenase increased	457.79	35.34	195	11522	25886	42583732
Cytokine release syndrome	409.41	35.34	213	11504	44314	42565304
Lymphoma	397.24	35.34	149	11568	14172	42595446
Diffuse large B-cell lymphoma recurrent	372.04	35.34	109	11608	4777	42604841
COVID-19	315.59	35.34	258	11459	115690	42493928
Off label use	283.82	35.34	570	11147	637765	41971853
Neutrophil count decreased	256.45	35.34	179	11538	63236	42546382
Cytomegalovirus infection reactivation	177.57	35.34	78	11639	11100	42598518
Cytopenia	172.89	35.34	88	11629	17409	42592209
Lymphocyte count decreased	165.12	35.34	100	11617	27709	42581909
Myelosuppression	155.91	35.34	111	11606	40350	42569268
White blood cell count decreased	138.73	35.34	161	11556	110235	42499383
Platelet count decreased	138.47	35.34	180	11537	138401	42471217
Hypogammaglobulinaemia	135.78	35.34	66	11651	11825	42597793
Neutropenia	129.24	35.34	211	11506	199220	42410398
Neoplasm progression	129.16	35.34	87	11630	28913	42580705
Febrile neutropenia	115.58	35.34	193	11524	185510	42424108
Diffuse large B-cell lymphoma refractory	115.20	35.34	36	11681	1961	42607657
Immune effector cell-associated neurotoxicity syndrome	112.50	35.34	54	11663	9407	42600211
Ill-defined disorder	95.13	35.34	58	11659	16238	42593380
Malignant neoplasm progression	91.72	35.34	130	11587	108270	42501348
Cytomegalovirus infection	87.73	35.34	72	11645	32234	42577384
Anaemia	86.63	35.34	218	11499	280060	42329558
Infection	79.85	35.34	124	11593	111944	42497674
Death	69.52	35.34	284	11433	470901	42138717
Toxoplasmosis	64.44	35.34	22	11695	1585	42608033
Neuropathy peripheral	62.04	35.34	105	11612	101748	42507870
Lymphadenopathy	61.97	35.34	60	11657	33305	42576313
Aspartate aminotransferase increased	57.18	35.34	87	11630	77076	42532542
Disease recurrence	56.30	35.34	54	11663	29624	42579994
Hypoalbuminaemia	53.64	35.34	40	11677	15570	42594048
Progressive multifocal leukoencephalopathy	52.26	35.34	35	11682	11501	42598117
Thrombocytopenia	51.46	35.34	141	11576	190138	42419480
Lymphoma transformation	50.02	35.34	14	11703	518	42609100
Dyspnoea	48.64	35.34	31	11686	442590	42167028
Neoplasm	46.17	35.34	26	11691	6279	42603339
Cystitis viral	45.91	35.34	16	11701	1226	42608392
Human polyomavirus infection	45.16	35.34	16	11701	1287	42608331
Arthralgia	44.74	35.34	3	11714	205235	42404383
Hyperuricaemia	43.67	35.34	29	11688	9395	42600223
Oral fungal infection	43.44	35.34	17	11700	1804	42607814
Hepatitis B	42.03	35.34	25	11692	6686	42602932
Dizziness	41.41	35.34	9	11708	249245	42360373
Diffuse large B-cell lymphoma	38.82	35.34	27	11690	9427	42600191
Tumour lysis syndrome	37.60	35.34	38	11679	22193	42587425
Haematotoxicity	37.40	35.34	28	11689	10957	42598661
Bacteraemia	37.32	35.34	40	11677	25000	42584618
Fatigue	37.29	35.34	39	11678	435602	42174016
COVID-19 pneumonia	36.65	35.34	37	11680	21576	42588042
Candida pneumonia	36.43	35.34	12	11705	774	42608844

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	2164.65	34.10	962	17099	243072	110328166
Neutrophil count decreased	696.35	34.10	356	17705	120585	110450653
Cytokine release syndrome	692.70	34.10	300	17761	70006	110501232
Blood lactate dehydrogenase increased	644.32	34.10	250	17811	44084	110527154
Diffuse large B-cell lymphoma recurrent	603.99	34.10	151	17910	6148	110565090
COVID-19	440.79	34.10	345	17716	244715	110326523
Platelet count decreased	439.68	34.10	336	17725	230107	110341131
Lymphocyte count decreased	429.13	34.10	202	17859	57041	110514197
White blood cell count decreased	397.46	34.10	316	17745	229074	110342164
Febrile neutropenia	381.10	34.10	354	17707	316413	110254825
Off label use	370.45	34.10	775	17286	1499410	109071828
Myelosuppression	368.21	34.10	215	17846	94125	110477113
Neutropenia	334.56	34.10	356	17705	374264	110196974
Lymphoma	325.95	34.10	123	17938	20048	110551190
Anaemia	276.58	34.10	390	17671	546696	110024542
Cytomegalovirus infection reactivation	271.80	34.10	105	17956	18228	110553010
Cytopenia	262.24	34.10	118	17943	29998	110541240
Diffuse large B-cell lymphoma refractory	209.82	34.10	54	18007	2467	110568771
Cytomegalovirus infection	204.13	34.10	121	17940	54323	110516915
Neuropathy peripheral	184.15	34.10	184	17877	179093	110392145
Immune effector cell-associated neurotoxicity syndrome	181.84	34.10	74	17987	14708	110556530
Malignant neoplasm progression	169.83	34.10	174	17887	174393	110396845
Hypogammaglobulinaemia	169.47	34.10	77	17984	19999	110551239
Death	167.04	34.10	358	17703	698511	109872727
Thrombocytopenia	157.27	34.10	236	17825	348649	110222589
Hypoalbuminaemia	134.35	34.10	74	17987	28900	110542338
Neoplasm progression	126.75	34.10	96	17965	64499	110506739
Tumour lysis syndrome	119.46	34.10	70	17991	30731	110540507
Lymphadenopathy	114.60	34.10	90	17971	63745	110507493
Arthralgia	103.41	34.10	6	18055	779626	109791612
Lymphoma transformation	97.07	34.10	22	18039	582	110570656
Aspartate aminotransferase increased	89.34	34.10	120	17941	159816	110411422
Haematotoxicity	87.29	34.10	50	18011	21032	110550206
Hyperuricaemia	86.90	34.10	44	18017	14487	110556751
Hypokalaemia	84.29	34.10	125	17936	182323	110388915
Septic shock	81.65	34.10	114	17947	157414	110413824
Pyrexia	77.91	34.10	321	17740	897944	109673294
Neoplasm	73.48	34.10	36	18025	11051	110560187
Dizziness	73.08	34.10	13	18048	698180	109873058
Cytomegalovirus test positive	72.32	34.10	31	18030	7005	110564233
Headache	72.27	34.10	27	18034	882350	109688888
Pain	72.13	34.10	33	18028	954922	109616316
Sepsis	70.28	34.10	161	17900	327185	110244053
COVID-19 pneumonia	68.01	34.10	53	18008	37090	110534148
Disease recurrence	67.15	34.10	65	17996	60719	110510519
Hypocalcaemia	66.83	34.10	67	17994	65299	110505939
Coronavirus infection	66.28	34.10	32	18029	9513	110561725
Fatigue	66.11	34.10	61	18000	1215897	109355341
Cystitis viral	64.27	34.10	19	18042	1454	110569784
Cytomegalovirus enterocolitis	64.06	34.10	21	18040	2260	110568978
Hypoproteinaemia	63.77	34.10	27	18034	5918	110565320
Drug interaction	62.88	34.10	5	18056	500178	110071060
Dyspnoea	61.97	34.10	54	18007	1106818	109464420
Drug hypersensitivity	61.68	34.10	3	18058	454087	110117151
Toxoplasmosis	60.55	34.10	22	18039	3217	110568021
Alanine aminotransferase increased	60.48	34.10	108	17953	183665	110387573
Bacteraemia	59.83	34.10	52	18009	42338	110528900
Leukopenia	58.96	34.10	95	17966	148696	110422542
Gamma-glutamyltransferase increased	55.73	34.10	59	18002	61250	110509988
Condition aggravated	52.97	34.10	27	18034	734809	109836429
Human polyomavirus infection	52.26	34.10	17	18044	1785	110569453
Retroperitoneal lymphadenopathy	51.81	34.10	16	18045	1420	110569818
Progressive multifocal leukoencephalopathy	48.72	34.10	37	18024	24919	110546319
Gastrointestinal obstruction	48.63	34.10	17	18044	2223	110569015
Hypertension	48.20	34.10	12	18049	510072	110061166
Opportunistic infection	47.93	34.10	19	18042	3524	110567714
Pruritus	47.20	34.10	18	18043	581542	109989696
Insomnia	47.05	34.10	3	18058	360587	110210651
Oral fungal infection	47.03	34.10	20	18041	4432	110566806
Bronchopulmonary aspergillosis	44.92	34.10	38	18023	29825	110541413
Candida pneumonia	43.53	34.10	13	18048	1030	110570208
Hypersensitivity	43.37	34.10	7	18054	403991	110167247
Abdominal pain upper	42.47	34.10	4	18057	349107	110222131
Procalcitonin increased	42.11	34.10	18	18043	4038	110567200
Product dose omission issue	41.03	34.10	3	18058	321779	110249459
Infection	40.82	34.10	141	17920	362059	110209179
Gastrointestinal perforation	40.03	34.10	21	18040	7435	110563803
Alopecia	39.88	34.10	6	18055	364747	110206491
Weight increased	39.38	34.10	10	18051	419634	110151604
Vomiting	39.26	34.10	55	18006	910620	109660618
Neutropenic infection	39.06	34.10	16	18045	3229	110568009
Diffuse large B-cell lymphoma	38.84	34.10	27	18034	15871	110555367
Follicular lymphoma	38.53	34.10	11	18050	744	110570494
Hepatic function abnormal	38.10	34.10	59	18002	89236	110482002
Pain in extremity	38.01	34.10	16	18045	487102	110084136
Ureteric compression	37.56	34.10	9	18052	305	110570933
Chest pain	37.24	34.10	8	18053	376367	110194871

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FX14	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates
CHEBI has role	CHEBI:35610	antineoplastic agent

Related Drugs by ATC class:

L01FX Other monoclonal antibodies and antibody drug conjugates 29 drugs

amivantamabbelantamab mafodotinblinatumomabbrentuximab vedotincatumaxomabdatopotamab deruxtecanelotuzumabelranatamabenfortumab vedotinepcoritamabgemtuzumab ozogamicinglofitamab show all 29 →

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

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Tubulin beta	Tumour-associated antigen	P07437 Q9H4B7 Q13885 Q9BVA1 Q13509 P04350 P68371 Q9BUF5 Q3ZCM7	TBB5_HUMAN TBB1_HUMAN TBB2A_HUMAN TBB2B_HUMAN TBB3_HUMAN TBB4A_HUMAN TBB4B_HUMAN TBB6_HUMAN TBB8_HUMAN	BINDING AGENT				UNKNOWN	DRUG LABEL
B-cell antigen receptor complex-associated protein beta chain	Tumour-associated antigen	P40259	CD79B_HUMAN	ANTIBODY BINDING				UNKNOWN	DRUG LABEL

External reference:

ID	Source
KG6VO684Z6	UNII
4038478	VANDF
4038479	VANDF
C4078806	UMLSCUI
CHEBI:755266	CHEBI
CHEMBL3301582	ChEMBL_ID
DB12240	DRUGBANK_ID
D10761	KEGG_DRUG
9714	INN_ID
C000600736	MESH_SUPPLEMENTAL_RECORD_UI
8404	IUPHAR_LIGAND_ID
788328006	SNOMEDCT_US
788329003	SNOMEDCT_US
318099	MMSL
37058	MMSL
d09309	MMSL
018025	NDDF
2174090	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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