ADC Name	Gemtuzumab ozogamicin
Brand Name	Mylotarg
Synonyms	gemtuzumab ozogamicin; Mylotarg; gemtuzumab; gemtuzumab ozogamycin; CMA-676; CDP-771; hP67.6    Click to Show/Hide
Organization	Celltech (Originator) (No Rights);Wyeth (Top20 MNC)
Drug Status	Approved in 2000 (withdrawn in 2010, approved again in 2017)
Drug-to-Antibody Ratio	2~3
Structure
	3D MOL			2D MOL
Antibody Name	Gemtuzumab					Antibody Info
Antigen Name	Myeloid cell surface antigen CD33 (CD33)					Antigen Info
Payload Name	N-acetyl-gamma-calicheamicin					Payload Info
Payload Target	Human deoxyribonucleic acid (hDNA)					Target Info
Linker Name	AcButDMH					Linker Info
Conjugate Type	Random Lysines
Combination Type	ozogamicin
Special Approval(s)	Accelerated approval (FDA); Orphan drug (FDA); Orphan drug (EMA)

Bystander Killing Effect	Description	Reference
no	Undisclosed	[1]

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	132±136	h/liter	After i.v. administration of the 9 mg/m2 dose,Corresponding AUCs were 132±136 and 243±198 mg h/liter for dose periods 1 and 2, respectively.	[1]
Maximum Observed Concentration (Cmax)	2.86	mg/L	Summary of hP67.6 Pharmacokinetic Parameters in Patients Receiving 9 mg/m2 Intravenous Infusion Doses of Gemtuzumab Ozogamicin, Dose period 1 (n=59).	[2]
Area Under the Concentration-Time Curve (AUC)	123	mg·h/L	Summary of hP67.6 Pharmacokinetic Parameters in Patients Receiving 9 mg/m2 Intravenous Infusion Doses of Gemtuzumab Ozogamicin, Dose period 1 (n=59).	[2]
Maximum Observed Concentration (Cmax)	3.67	mg/L	Summary of hP67.6 Pharmacokinetic Parameters in Patients Receiving 9 mg/m2 Intravenous Infusion Doses of Gemtuzumab Ozogamicin, Dose period 2 (n=49).	[2]
Area Under the Concentration-Time Curve (AUC)	239	mg·h/L	Summary of hP67.6 Pharmacokinetic Parameters in Patients Receiving 9 mg/m2 Intravenous Infusion Doses of Gemtuzumab Ozogamicin, Dose period 2 (n=49).	[2]
Maximum Observed Concentration (Cmax)	1.70±1.12	mg/L	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Area Under the Concentration-Time Curve (AUC)	48.8±47.6	mg·h/L	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Maximum Observed Concentration (Cmax)	1.94±1.09	mg/L	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Area Under the Concentration-Time Curve (AUC)	79.7±66.2	mg·h/L	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Maximum Observed Concentration (Cmax)	3.11	mg/L	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Area Under the Concentration-Time Curve (AUC)	112	mg·h/L	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Maximum Observed Concentration (Cmax)	3	mg/L	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Area Under the Concentration-Time Curve (AUC)	153	mg·h/L	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Maximum Observed Concentration (Cmax)	3.47±1.04	mg/L	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Area Under the Concentration-Time Curve (AUC)	136±107	mg·h/L	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Maximum Observed Concentration (Cmax)	4.68±2.18	mg/L	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Area Under the Concentration-Time Curve (AUC)	241±157	mg·h/L	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Maximum Observed Concentration (Cmax)	1.58±1.16	mg/L	6 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Area Under the Concentration-Time Curve (AUC)	46.2±54.5	mg·h/L	6 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Maximum Observed Concentration (Cmax)	2.14±1.66	mg/L	6 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Area Under the Concentration-Time Curve (AUC)	41.1±48	mg·h/L	6 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Maximum Observed Concentration (Cmax)	1.49±0.8	mg/L	6 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Area Under the Concentration-Time Curve (AUC)	54.3±51.9	mg·h/L	6 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Maximum Observed Concentration (Cmax)	3.11±0.55	mg/L	7.5 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Area Under the Concentration-Time Curve (AUC)	113±37.7	mg·h/L	7.5 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Maximum Observed Concentration (Cmax)	3.54±0.83	mg/L	9 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Area Under the Concentration-Time Curve (AUC)	134±36.7	mg·h/L	9 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Maximum Observed Concentration (Cmax)	3.76±1	mg/L	9 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Area Under the Concentration-Time Curve (AUC)	184±163	mg·h/L	9 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Maximum Observed Concentration (Cmax)	3.24±1.19	mg/L	9 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Area Under the Concentration-Time Curve (AUC)	102±59.6	mg·h/L	9 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Maximum Observed Concentration (Cmax)	5.86±1.35	mg/L	9 Mg/m2, first dose, Administered in Adults AML patients in first relapse,period 2.	[3]
Area Under the Concentration-Time Curve (AUC)	123±105	mg·h/L	9 Mg/m2, first dose, Administered in Adults AML patients in first relapse,period 2.	[3]
Maximum Observed Concentration (Cmax)	2.99±1.63	mg/L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Men (n=29)	[4]
Area Under the Concentration-Time Curve (AUC)	137±124	mg·h/L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Men (n=29)	[4]
Maximum Observed Concentration (Cmax)	2.72±0.98	mg/L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Women (n=29)	[4]
Area Under the Concentration-Time Curve (AUC)	110±82	mg·h/L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Women (n=29)	[4]
Maximum Observed Concentration (Cmax)	3.03±1.36	mg/L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Age<60 yrs (n=34)	[4]
Area Under the Concentration-Time Curve (AUC)	129±91	mg·h/L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Age<60 yrs (n=34)	[4]
Maximum Observed Concentration (Cmax)	2.61±1.31	mg/L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Aged≥60 yrs (n=24)	[4]
Area Under the Concentration-Time Curve (AUC)	115±125	mg·h/L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Aged≥60 yrs (n=24)	[4]
Maximum Observed Concentration (Cmax)	2.86±1.35	mg/L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by All patients	[4]
Area Under the Concentration-Time Curve (AUC)	123±105	mg·h/L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by All patients	[4]
Maximum Observed Concentration (Cmax)	1.4	mg/L	Pediatric Patients (6 mg/m2)	[5]
Area Under the Concentration-Time Curve (AUC)	48.5	mg·h/L	Pediatric Patients (6 mg/m2)	[5]
Area Under the Concentration-Time Curve (AUC)	136±107	mg·h/L	In pediatric patients receiving a dose level of 9 mg/m2, the AUC was 136 ± 107 mg·h/L	[3]

Standard Type	Value	Units	Description	Reference
Volume of Distribution (Vd)	20.95	L	Summary of hP67.6 Pharmacokinetic Parameters in Patients Receiving 9 mg/m2 Intravenous Infusion Doses of Gemtuzumab Ozogamicin, Dose period 1 (n=59).	[2]
Volume of Distribution (Vd)	9.92	L	Summary of hP67.6 Pharmacokinetic Parameters in Patients Receiving 9 mg/m2 Intravenous Infusion Doses of Gemtuzumab Ozogamicin, Dose period 2 (n=49).	[2]
Volume of Distribution (Vd)	13.7±14.0	L	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Volume of Distribution (Vd)	12.5±13.1	L	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	6.3	L	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Volume of Distribution (Vd)	14.5	L	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	6.5±5.5	L	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Volume of Distribution (Vd)	3.9±2.1	L	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	2.3±1.2	L	6 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	0.19±0.1	L/kg	6 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	11.2±11.8	L	6 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	0.48±0.51	L/kg	6 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	20.1±15.5	L	6 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	0.36±0.28	L/kg	6 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	6.3±2.5	L	7.5 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	0.11±0.04	L/kg	7.5 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	2.9±2.7	L	9 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	0.24±0.22	L/kg	9 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	3.9±1.6	L	9 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	0.17±0.07	L/kg	9 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	9.4±6.6	L	9 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	0.17±0.12	L/kg	9 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	20.9±21.5	L	9 Mg/m2, first dose, Administered in Adults AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	0.3±0.31	L/kg	9 Mg/m2, first dose, Administered in Adults AML patients in first relapse,period 2.	[3]
Volume of Distribution (Vd)	20±20.8	L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Men (n=29)	[4]
Volume of Distribution (Vd)	21.9±22.6	L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Women (n=29)	[4]
Volume of Distribution (Vd)	19.2±19	L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Age<60 yrs (n=34)	[4]
Volume of Distribution (Vd)	23.4±24.9	L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Aged≥60 yrs (n=24)	[4]
Volume of Distribution (Vd)	20.9±21.5	L	HP67.6 Pharmacokinetics for the First Dose Period of Patients by All patients	[4]
Volume of Distribution (Vd)	6.37	L	Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia,volume of distribution in central compartment	[6]
Clearance (CL)	0.0861	L/h	Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia, intercompartmental clearance	[6]
Volume of Distribution (Vd)	8.58	L	Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia,volume of distribution in peripheral compartment	[6]

Description	Reference
Metabolic studies indicate hydrolytic release of the calicheamicin derivative from gemtuzumab ozogamicin. The drug is most likely removed by opsonization via the reticuloendothelial system.

Standard Type	Value	Units	Description	Reference
Clearance (CL)	0.12±0.15	L/h/m2	The mean clearance rate was approximately 0.12±0.15 L/h/m2 in pediatric patients receiving a dose level of 9mg/m2	[1]
Elimination Half-Life (t1/2)	64±44	h	In pediatric patients receiving a dose level of 9mg/m2 , the half life was approximately 64±44 h after the first dose	[1]
Elimination Half-Life (t1/2)	72.4	h	Summary of hP67.6 Pharmacokinetic Parameters in Patients Receiving 9 mg/m2 Intravenous Infusion Doses of Gemtuzumab Ozogamicin, Dose period 1 (n=59).	[2]
Clearance (CL)	0.265	L/h	Summary of hP67.6 Pharmacokinetic Parameters in Patients Receiving 9 mg/m2 Intravenous Infusion Doses of Gemtuzumab Ozogamicin, Dose period 1 (n=59).	[2]
Elimination Half-Life (t1/2)	93.7	h	Summary of hP67.6 Pharmacokinetic Parameters in Patients Receiving 9 mg/m2 Intravenous Infusion Doses of Gemtuzumab Ozogamicin, Dose period 2 (n=49).	[2]
Clearance (CL)	0.132	L/h	Summary of hP67.6 Pharmacokinetic Parameters in Patients Receiving 9 mg/m2 Intravenous Infusion Doses of Gemtuzumab Ozogamicin, Dose period 2 (n=49).	[2]
Elimination Half-Life (t1/2)	43.1±22.7	h	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Clearance (CL)	0.61±1.34	L/h	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Clearance (CL)	0.48±0.94	L/h/m2	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Elimination Half-Life (t1/2)	49.4±25.6	h	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.32±0.49	L/h	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.25±0.35	L/h/m2	6 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Elimination Half-Life (t1/2)	40	h	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Clearance (CL)	0.12	L/h	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Clearance (CL)	0.07	L/h/m2	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Elimination Half-Life (t1/2)	33.4	h	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.09	L/h	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.05	L/h/m2	7.5 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Elimination Half-Life (t1/2)	63.7±44.3	h	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Clearance (CL)	0.16±0.23	L/h	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Clearance (CL)	0.12±0.15	L/h/m2	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 1.	[3]
Elimination Half-Life (t1/2)	57.8±33.4	h	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.21±0.45	L/h	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.16±0.34	L/h/m2	9 Mg/m2, first dose, Administered in AML patients in first relapse,period 2.	[3]
Elimination Half-Life (t1/2)	30.6±8.9	h	6 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.16±0.16	L/h	6 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.29±0.30	L/h/m2	6 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Elimination Half-Life (t1/2)	32.9±18.2	h	6 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.27±0.22	L/h	6 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.29±0.18	L/h/m2	6 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Elimination Half-Life (t1/2)	52.5±25	h	6 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.99±1.87	L/h	6 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.68±1.34	L/h/m2	6 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Elimination Half-Life (t1/2)	40±7.4	h	7.5 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.12±0.06	L/h	7.5 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.07±0.02	L/h/m2	7.5 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Elimination Half-Life (t1/2)	113±108	h	9 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.03±0.02	L/h	9 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.05±0.02	L/h/m2	9 Mg/m2, first dose, Administered in Infants (0-2 years) AML patients in first relapse,period 2.	[3]
Elimination Half-Life (t1/2)	45.6±30.8	h	9 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.06±0.03	L/h	9 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.08±0.05	L/h/m2	9 Mg/m2, first dose, Administered in Children (3-11 years) AML patients in first relapse,period 2.	[3]
Elimination Half-Life (t1/2)	62±16.5	h	9 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.26±0.3	L/h	9 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.17±0.21	L/h/m2	9 Mg/m2, first dose, Administered in Adolescents (12-16 years) AML patients in first relapse,period 2.	[3]
Elimination Half-Life (t1/2)	72.4±42.0	h	9 Mg/m2, first dose, Administered in Adults AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.27±0.23	L/h	9 Mg/m2, first dose, Administered in Adults AML patients in first relapse,period 2.	[3]
Clearance (CL)	0.15±0.13	L/h/m2	9 Mg/m2, first dose, Administered in Adults AML patients in first relapse,period 2.	[3]
Elimination Half-Life (t1/2)	66.8±39.4	h	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Men (n=29)	[4]
Clearance (CL)	0.254±0.229	L/h	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Men (n=29)	[4]
Elimination Half-Life (t1/2)	77.9±44.5	h	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Women (n=29)	[4]
Clearance (CL)	0.288±0.232	L/h	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Women (n=29)	[4]
Elimination Half-Life (t1/2)	74.1±47.7	h	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Age<60 yrs (n=34)	[4]
Clearance (CL)	0.239±0.207	L/h	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Age<60 yrs (n=34)	[4]
Elimination Half-Life (t1/2)	69.8±33.1	h	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Aged≥60 yrs (n=24)	[4]
Clearance (CL)	0.304±0.258	L/h	HP67.6 Pharmacokinetics for the First Dose Period of Patients by Aged≥60 yrs (n=24)	[4]
Elimination Half-Life (t1/2)	72.4±42.0	h	HP67.6 Pharmacokinetics for the First Dose Period of Patients by All patients	[4]
Clearance (CL)	0.265±0.229	L/h	HP67.6 Pharmacokinetics for the First Dose Period of Patients by All patients	[4]
Clearance (CL)	0.296	L/h	Pediatric Patients (6 mg/m2)	[5]
Elimination Half-Life (t1/2)	51.6	h	Pediatric Patients (6 mg/m2)	[5]
Clearance (CL)	0.353	L/h	Adult Patients (9 mg/m2)	[5]
Elimination Half-Life (t1/2)	66.5	h	Adult Patients (9 mg/m2)	[5]
Clearance (CL)	0.117	L/h	Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia, linear clearance	[6]
Clearance (CL)	2.75	L/h	Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia, clearance associated with CLt, CLt time-dependent clearance	[6]

Description	Reference
The most frequently reported toxicities are myelosuppression and hepatic veno-occlusive disorder.

Standard Type	NCT Number	Clinical Status	Clinical Trial Description
Two-year Overall Survival (OS)	NCT00893399	Phase 3	Phase III study of chemotherapy in combination with atra with or without gemtuzumab ozogamicin in patients with acute myeloid leukemia and npm1 gene mutation.
Objective Response Rate (ORR)	NCT00909168	Phase 3	Induction, consolidation and intensification therapy for patients younger than 66 years with previously untreated CD33 positive acute myeloid leukemia (AML) (MYFLAI07).

Standard Type	Value	Units	Cell Line	Disease Model
Tumor Growth Inhibition value (TGI)	≈ 13.81	%	MV4-11 cells	Childhood acute monocytic leukemia

Standard Type	Value	Units	Cell Line	Disease Model
Half Maximal Inhibitory Concentration (IC50)	20	pM	ML-2 cells	Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	30	pM	EoL-1 cells	Chronic eosinophilic leukemia
Half Maximal Inhibitory Concentration (IC50)	30	pM	MOLM-13 cells	Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	40	pM	SKNO-1 cells	Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	70	pM	MV4-11 cells	Childhood acute monocytic leukemia
Half Maximal Inhibitory Concentration (IC50)	90	pM	OCI-AML-1 cells	Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	90	pM	HL-60 cells	Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	0.1	nM	Kasumi-6 cells	Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	0.1	nM	AML-193 cells	Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	0.1	nM	OCI-AML-4 cells	Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	> 0.41	nM	KOPN-8 cells	Leukemia
Half Maximal Inhibitory Concentration (IC50)	0.43	nM	MOLT-4 cells	Adult T acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50)	0.45	nM	SKM-1 cells	Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	0.52	nM	HNT-34 cells	Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	0.56	nM	RS4 11 cells	Adult B acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50)	0.58	nM	Reh cells	B acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50)	1.47	nM	LC4-1 cells	B acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50)	1.78	nM	SUP-B15 cells	B-lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50)	2.57	nM	THP-1 cells	Childhood acute monocytic leukemia
Half Maximal Inhibitory Concentration (IC50)	2.92	nM	TALL-1 cells	T acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50)	3.31	nM	LOUCY cells	Adult T acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50)	8.02	nM	NALM-16 cells	Childhood B acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50)	8.03	nM	ATN-1 cells	T acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50)	8.56	nM	CCRF-CEM cells	T acute lymphoblastic leukemia
Half Maximal Inhibitory Concentration (IC50)	8.61	nM	SUP-T1 cells	T lymphoblastic lymphoma
Half Maximal Inhibitory Concentration (IC50)	8.91	nM	ARH-77 cells	Leukemia
Half Maximal Inhibitory Concentration (IC50)	10.2	nM	Jurkat E6.1 cells	Leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	GDM-1 cells	Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	TF-1a cells	Acute erythroid leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	KU812 cells	Chronic myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	CMK-11-5 cells	Acute megakaryoblastic leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	PLB-985 cells	Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	OCI-M1 cells	Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	Kasumi-1 cells	Myeloid leukemia with maturation
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	NOMO-1 cells	Acute monocytic leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	KG-1a cells	Leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	Kasumi-3 cells	Adult acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	AML-193 cells	Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	Kasumi-6 cells	Acute myeloid leukemia
Half Maximal Inhibitory Concentration (IC50)	> 20	nM	F-36P cells	Myelodysplastic syndrome

Experiment 1 Reporting the Activity Date of This ADC					[7]
Efficacy Data	Two-year Overall Survival (OS)	69.00 (standard group); 73.00 (gemtuzumab ozogamicin group) %
Patients Enrolled	Eligible participants were 18 years or older and had newly diagnosed NPM1-mutated acute myeloid leukaemia and an Eastern Cooperative Oncology Group performance status of 0-2.
Administration Dosage	Participants received two cycles of induction therapy plus all-trans retinoic acid (ATRA) followed by three consolidation cycles of high-dose cytarabine and ATRA, without or with gemtuzumab ozogamicin (3 mg/m2 i.v.on day 1 of induction cycles 1 and 2, and consolidation cycle 1).
Related Clinical Trial
NCT Number	NCT00893399	Clinical Status	Phase 3
Clinical Description	Phase III study of chemotherapy in combination with atra with or without gemtuzumab ozogamicin in patients with acute myeloid leukemia and npm1 gene mutation.
Primary Endpoint	Short-term event-free survival at 6-month follow-up, 53.00% in the standard group and 58.00% in the gemtuzumab ozogamicin group.
Other Endpoint	CRi rates, n=267 (90%) in the standard group vs n=251 (86%) in the gemtuzumab ozogamicin group.
Experiment 2 Reporting the Activity Date of This ADC					[8]
Efficacy Data	Objective Response Rate (ORR)	85%	Positive CD33 expression (CD33+++/++)
Patients Enrolled	Previously untreated primary or secondary acute myeloid leukemia (with bone marrow blasts 20%), express CD33 on blast cells.
Administration Dosage	3 mg/sqm single dose on day 6.
Related Clinical Trial
NCT Number	NCT00909168	Clinical Status	Phase 3
Clinical Description	Induction, consolidation and intensification therapy for patients younger than 66 years with previously untreated CD33 positive acute myeloid leukemia (AML) (MYFLAI07).
Primary Endpoint	Objective response rate=85.00%, comprising 82.00% complete responses and 3.00% partial responses.
Other Endpoint	median DFS=61 months, median OS=63 months.

Experiment 1 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 13.81%	Positive CD33 expression (CD33+++/++)
Method Description	Subcutaneous tumor model MV4-11 human acute myelocytic leukemia cells (1x10 cells in 0.1 mL) were subcutaneously inoculated into the right flank of female athymic nude mice. Mice were treated with ADCs (iv, 0.1 mg/kg x 1) when tumors reached 150 mm3 and mouse body weight were measured twice per week.
In Vivo Model	MV411 CDX model
In Vitro Model	Childhood acute monocytic leukemia	MV4-11 cells		CVCL_0064

Experiment 1 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	20 pM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute myeloid leukemia	ML-2 cells		CVCL_1418
Experiment 2 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	30 pM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Chronic eosinophilic leukemia	EoL-1 cells		CVCL_0258
Experiment 3 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	30 pM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Adult acute myeloid leukemia	MOLM-13 cells		CVCL_2119
Experiment 4 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	40 pM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Adult acute myeloid leukemia	SKNO-1 cells		CVCL_2196
Experiment 5 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	70 pM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Childhood acute monocytic leukemia	MV4-11 cells		CVCL_0064
Experiment 6 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	90 pM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Adult acute myeloid leukemia	OCI-AML-1 cells		CVCL_5228
Experiment 7 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	90 pM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Adult acute myeloid leukemia	HL-60 cells		CVCL_0002
Experiment 8 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.1 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute myeloid leukemia	Kasumi-6 cells		CVCL_0614
Experiment 9 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.1 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute myeloid leukemia	AML-193 cells		CVCL_1071
Experiment 10 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.1 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute myeloid leukemia	OCI-AML-4 cells		CVCL_5224
Experiment 11 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 0.41 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Leukemia	KOPN-8 cells		CVCL_1866
Experiment 12 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.43 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Adult T acute lymphoblastic leukemia	MOLT-4 cells		CVCL_0013
Experiment 13 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.45 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute myeloid leukemia	SKM-1 cells		CVCL_0098
Experiment 14 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.52 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute myeloid leukemia	HNT-34 cells		CVCL_2071
Experiment 15 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.56 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Adult B acute lymphoblastic leukemia	RS4;11 cells		CVCL_0093
Experiment 16 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.58 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	B acute lymphoblastic leukemia	Reh cells		CVCL_1650
Experiment 17 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	1.47 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	B acute lymphoblastic leukemia	LC4-1 cells		CVCL_1374
Experiment 18 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	1.78 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	B-lymphoblastic leukemia	SUP-B15 cells		CVCL_0103
Experiment 19 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	2.57 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Childhood acute monocytic leukemia	THP-1 cells		CVCL_0006
Experiment 20 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	2.92 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	T acute lymphoblastic leukemia	TALL-1 cells		CVCL_1736
Experiment 21 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	3.31 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Adult T acute lymphoblastic leukemia	LOUCY cells		CVCL_1380
Experiment 22 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	8.02 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Childhood B acute lymphoblastic leukemia	NALM-16 cells		CVCL_1834
Experiment 23 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	8.03 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	T acute lymphoblastic leukemia	ATN-1 cells		CVCL_1073
Experiment 24 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	8.56 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	T acute lymphoblastic leukemia	CCRF-CEM cells		CVCL_0207
Experiment 25 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	8.61 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	T lymphoblastic lymphoma	SUP-T1 cells		CVCL_1714
Experiment 26 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	8.91 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Leukemia	ARH-77 cells		CVCL_1072
Experiment 27 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	10.2 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Leukemia	Jurkat E6.1 cells		CVCL_0367
Experiment 28 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute myeloid leukemia	GDM-1 cells		CVCL_1230
Experiment 29 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute erythroid leukemia	TF-1a cells		CVCL_3608
Experiment 30 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Chronic myeloid leukemia	KU812 cells		CVCL_0379
Experiment 31 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Negative CD33 expression (CD33-)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute megakaryoblastic leukemia	CMK-11-5 cells		CVCL_0217
Experiment 32 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Adult acute myeloid leukemia	PLB-985 cells		CVCL_2162
Experiment 33 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute myeloid leukemia	OCI-M1 cells		CVCL_2149
Experiment 34 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Myeloid leukemia with maturation	Kasumi-1 cells		CVCL_0589
Experiment 35 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute monocytic leukemia	NOMO-1 cells		CVCL_1609
Experiment 36 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Leukemia	KG-1a cells		CVCL_1824
Experiment 37 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Adult acute myeloid leukemia	Kasumi-3 cells		CVCL_0612
Experiment 38 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute myeloid leukemia	AML-193 cells		CVCL_1071
Experiment 39 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Acute myeloid leukemia	Kasumi-6 cells		CVCL_0614
Experiment 40 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	> 20 nM	Positive CD33 expression (CD33+++/++)
Method Description	The cells, at a predetermined concentration, were plated into 96 well plates, and, after overnight incubation at 37°C/5% CO2, serial dilutions of each test article (TA) were added to the cells. Cells were incubated with test articles for 72 hours. and viability was detected with CellTiter-Gloreagent.
In Vitro Model	Myelodysplastic syndrome	F-36P cells		CVCL_2037

Ref 1	Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia
Ref 2	Pharmacokinetics of gemtuzumab ozogamicin, an antibody-targeted chemotherapy agent for the treatment of patients with acute myeloid leukemia in first relapse
Ref 3	Pharmacokinetics of gemtuzumab ozogamicin as a single-agent treatment of pediatric patients with refractory or relapsed acute myeloid leukemia
Ref 4	Impact of age and gender on the pharmacokinetics of gemtuzumab ozogamicin
Ref 5	Gemtuzumab Ozogamicin
Ref 6	Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia
Ref 7	Intensive chemotherapy with or without gemtuzumab ozogamicin in patients with NPM1-mutated acute myeloid leukaemia (AMLSG 09-09): a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2023 Jul;10(7):e495-e509. doi: 10.1016/S2352-3026(23)00089-3. Epub 2023 May 12.
Ref 8	Flai (fludarabine, cytarabine, idarubicin) plus low-dose Gemtuzumab Ozogamicin as induction therapy in CD33-positive AML: Final results and long term outcome of a phase II multicenter clinical trial. Am J Hematol. 2018 May;93(5):655-663. doi: 10.1002/ajh.25057. Epub 2018 Mar 2.
Ref 9	Neodegrader conjugates; 2021-10-07.