← Atlas
Gemtuzumab ozogamicin FDA-approved Mylotarg; CMA-676
RP2D dose
3 mg/m² (max 4.5 mg) D1+D4+D7 induction RP2D
01 Multi-organ toxicity
Fingerprint & organ drill-down Any-grade Grade 3+
Ocular
0%
Hepatic
51%
Neutrop.
-
Thrombo.
-
Anemia
-
GI
21%
ILD
-
Neuro.
-
Also reported Other · 646 · 17 systems
18 adverse-event terms
Ocular Toxicity Target expression Compare
sagittal schematic · Unknown
↳ Tissues shaded by reported adverse-event rate.
Reported ocular events
Retinoic acid syndrome 7.14%
Eye disorders - Other, specifyL eye hemorrhage 6.25%
EYE DISORDERS - OTHER, SPECIFY 5.56%
Vision-blurred vision 1.83%
Watery eye (epiphora, tearing) 1.82%
Eye disorders - Other 0.29%
Per-trial detail
Adverse events by trial Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients W · PHASE3 — 291 events, n=1028 Combination Chemotherapy With or Without G (NCT00372593) · Phase 3 — 291 events, n=511 S0521, Combination Chemotherapy With or Wi (NCT00492856) · Phase 3 — 127 events, n=1 Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating · PHASE3 — 125 events, n=653 Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously · PHASE2 — 120 events, n=165 Azacitidine and Gemtuzumab Ozogamicin in T (NCT00658814) · Phase 2 — 120 events, n=133 Phase II Study of the Combination of Mitox (NCT03839446) · Phase 2 — 116 events, n=16 S0535, Gemtuzumab and Combination Chemothe (NCT00551460) · Phase 2 — 107 events, n=70 S0106 Cytarabine and Daunorubicin w/ or w/ (NCT00085709) · Phase 3 — 92 events, n=293 S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine · PHASE3 — 91 events, n=1039 Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte I · PHASE1|PHASE2 — 84 events, n=11 Gemtuzumab Ozogamicin With G-CSF, Cladribi (NCT03531918) · Phase 1/2 — 82 events, n=6 Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untr · PHASE1|PHASE2 — 81 events, n=66 Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozog · PHASE2 — 81 events, n=16 Study of the Safety and Efficacy of Gemtuz (NCT04070768) · Phase 1 — 78 events, n=3 Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in · PHASE1 — 77 events, n=18 S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previou · PHASE2 — 73 events, n=70 Treatment of Patients With Newly Diagnosed (NCT00136084) · Phase 3 — 69 events, n=114 AflacLL1901 (CHOA-AML) (NCT04326439) · Phase 2 — 65 events, n=8 AflacLL1901 (CHOA-AML) · PHASE2 — 64 events, n=22 Vorinostat, Azacitidine, and Gemtuzumab Ozogamicin for Older Patients With Relap · PHASE1|PHASE2 — 59 events, n=58 Vorinostat, Azacitidine, and Gemtuzumab Oz (NCT00895934) · Phase 1/2 — 59 events, n=15 Vorinostat and Gemtuzumab Ozogamicin in Tr (NCT00673153) · Phase 2 — 55 events, n=31 OX40, Venetoclax, Avelumab, Glasdegib, Gem (NCT03390296) · Phase 1/2 — 50 events, n=21 OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in · PHASE1|PHASE2 — 49 events, n=50 Evaluating QTc, PK, Safety of Gemtuzumab O (NCT03727750) · Phase 4 — 46 events, n=50 Vorinostat and Gemtuzumab Ozogamicin in Treating Older Patients With Previously · PHASE2 — 46 events, n=31 All-trans Retinoic Acid, and Arsenic +/- I (NCT00413166) · Phase 2 — 29 events, n=16 All-trans Retinoic Acid, and Arsenic +/- Idarubicin · PHASE2 — 28 events, n=78 Arsenic Trioxide and Gemtuzumab Ozogamicin (NCT00274781) · Phase 2 — 24 events, n=30 Combination 5-azacitidine and Gemtuzumab O (NCT00766116) · Phase 1/2 — 23 events, n=50 Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced My · PHASE2 — 19 events, n=30 MyloFrance-1 (Taksin 2007) · Phase 2 — 17 events, n=57 Prospective Study of Mylotarg and G-CSF in (NCT01698879) · Phase 2 — 17 events, n=20 MyloFrance-1 · Approved — 16 events, n=57 Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment · PHASE2 — 16 events, n=25 ALFA-0701 (NCT00927498) · Phase 3 — 15 events, n=131 AML-19 / EORTC-GIMEMA (NCT00091234) · Phase 3 — 12 events, n=111 AAML0531 (NCT00372593) · Phase 3 — 11 events, n=520 ALFA-0701 · Approved — 9 events, n=131 AAML0531 (NCT00372593) · Phase 3 — 8 events, n=520 AML-19 · Approved — 8 events, n=111 ALFA-0701 (NCT00927498) · Phase 3 — 5 events, n=131 Decitabine and Gemtuzumab Ozogamicin in Ac (NCT00882102) · Phase 2 — 5 events, n=40 Decitabine and Gemtuzumab Ozogamicin in Ac (NCT00968071) · Phase 2 — 4 events, n=71 Unattributed cohort — 4 events AAML0531 (NCT00372593) · Phase 3 — 2 events, n=300 Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk · PHASE2 — 2 events, n=71 Unattributed cohort — 2 events AAML0531 (NCT00372593) · Phase 3 — 1 event, n=187 Unattributed cohort — 1 event Unattributed cohort — 1 event Unattributed cohort — 1 event Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients W PHASE3 real-world n=1028 CTCAE NR (ClinicalTrials.gov C
291 adverse-event terms · 22 systems · expand a system below
Mucositis oral
17.32% non-serious
Diarrhea
13.52% non-serious
Abdominal pain
7.98% non-serious
Oral pain
6.13% non-serious
Typhlitis
5.84% non-serious
Esophagitis
2.33% non-serious
Rectal pain
2.24% non-serious
Anal pain
1.36% non-serious
Gastritis
1.17% non-serious
Gastrointestinal disorders - Other
1.07% non-serious
Lower gastrointestinal hemorrhage
0.88% non-serious
Anal mucositis
0.78% non-serious
Abdominal distension
0.68% non-serious
Dysphagia
0.68% non-serious
Pancreatitis
0.68% non-serious
Esophageal pain
0.49% non-serious
Enterocolitis
0.39% non-serious
Oral hemorrhage
0.39% non-serious
Toothache
0.39% non-serious
Upper gastrointestinal hemorrhage
0.39% non-serious
Rectal mucositis
0.29% non-serious
Stomach pain
0.29% non-serious
Dyspepsia
0.19% non-serious
Gingival pain
0.19% non-serious
Rectal hemorrhage
0.19% non-serious
Small intestinal obstruction
0.19% non-serious
Anal ulcer
0.1% non-serious
Colonic fistula
0.1% non-serious
Colonic hemorrhage
0.1% non-serious
Constipation
0.1% non-serious
Dental caries
0.1% non-serious
Duodenal hemorrhage
0.1% non-serious
Esophageal hemorrhage
0.1% non-serious
Gastric hemorrhage
0.1% non-serious
Gastrointestinal pain
0.1% non-serious
Hemorrhoids
0.1% non-serious
Intra-abdominal hemorrhage
0.1% non-serious
Malabsorption
0.1% non-serious
Rectal fistula
0.1% non-serious
Small intestinal mucositis
0.1% non-serious
Photophobia
0.68% non-serious
Blurred vision
0.39% non-serious
Eye disorders - Other
0.29% non-serious
Eye infection
0.29% non-serious
Conjunctivitis
0.19% non-serious
Vitreous hemorrhage
0.1% non-serious
02 Construct
Molecular anatomy Linker structure C12H15NO3
CC(=O)c1ccc(OCCCC(N)=O)cc1 copy
Payload structure C55H74IN3O21S4
CCN[C@H]1CO[C@H](C[C@@H]1OC)O[C@@H]2[C@H]([C@@H]([C@H](O[C@H]2O[C@H]3C#C/C=C\\C#C[C@@]\\4(CC(=O)C(=C3/C4=C\\CSSSC)NC(=O)OC)O)C)NO[C@H]5C[C@@H]([C@@H]([C@H](O5)C)SC(=O)C6=C(C(=C(C(=C6OC)OC)O[C@H]7[C@@H]([C@@H]([C@H]([C@@H](O7)C)O)OC)O)I)C)O)O copy
03 Antibody
Antibody & Fc engineering Fc modifications
None inferred
Glycoengineering
Standard inferred
Effector silencing
None inferred
Linker
AcBut hydrazone + disulfide
Conjugation
Conventional Lys (NHS)
DAR homogeneity
Heterogeneous
Cleavage trigger
pH/acid (hydrazone) + GSH/reductive (disulfide)
Release control
Conditional
Hydrophilicity mask
None inferred
Stability note
Terminal t½ ~62 h after dose 1, ~90 h after dose 2 (9 mg/m² regimen); acid-labile hydrazone + disulfide intentionally plasma-labile, implicated in hepatotoxicity / VOD-SOS
Payload
Calicheamicin gamma1
Mechanism
DNA strand break
Released catabolite
N-acetyl-γ-calicheamicin (active calicheamicin derivative), released from the conjugated N-acetyl-γ-calicheamicin dimethylhydrazide (N-Ac-γ-cal-DMH) by nonenzymatic reduction of the disulfide bond
Mechanistic subtype
DNA-strand-break
Plasma protein binding (%)
97 %
Hydrophobicity · logD₇.₄
hydrophilic −2 +2 +4 lipophilic
Bioactivity note
ADCdb (DRG0JOHND) reports payload/ADC potency against CD33+ cells with most potent IC50 ~20 pM (ML-2) and ~30 pM (MOLM-13, EoL-1); clinical objective response rate ~85% in CD33+ AML. Calicheamicin warhead induces sequence-selective double-strand DNA breaks (ADCdb lists the mechan
RP2D dose
3 mg/m² (max 4.5 mg)
Schedule
D1+D4+D7 induction
07 Pharmacology
Clinical pharmacokinetics By analyte · FDA label §12.3 + Drugs@FDA clinical-pharmacology reviews
Intact ADC Total antibody Free payload Cmax — 3.0 mg/L +1
— Tmax 2 h
2 h
2 h
t½ ~41 h +1
62 h +3
— CL — 0.35 L/h +1
— Vd — 21.4 L +2
—
hover a value for dose / population / source · “+N” marks additional reported values
08 Ocular & expression
Ocular profile & eye-tissue target expression Target profile → OAE data status
documented-absent
Grading scale
CTCAE v3.0 locator?
Target expression in eye tissues (HCA detection · HPA bulk)
Cross-trial comparability
Ascertainment: Symptom-driven reporting Scale: Unknown Denominator: RP2D ⚠ Not comparable: symptom-driven ascertainment + grading scale not documented
Ocular AE grading reference — interspecialty consensus · 6 scales + dose modification 09 Identity & registry
Identifiers, registry & notes ADC id
gemtuzumab-ozogamicin
Approval status
FDA-approved
Primary source
FDA Mylotarg label (DailyMed)
Aliases & development codes
Mylotarg; CMA-676
Notes
Hematologic target; both routes to cornea closed (no expression + hydrophilic payload). V3.1: n=131 (ALFA-0701 pivotal, basis for 2017 reapproval); prior 242 not in label.