Last update 27 Mar 2025

Gemtuzumab Ozogamicin

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Anti-CD33-monoclonal-antibody-calicheamicin, Anti-CD33-monoclonal-antibody-p67-6-calicheamicin-conjugate, Gemtuzumab
+ [17]
Action
inhibitors
Mechanism
CD33 inhibitors(Myeloid cell surface antigen CD33 inhibitors), DNA inhibitors(DNA inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (17 May 2000),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Japan)
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Structure/Sequence

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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute Myeloid Leukemia
Japan
25 Jul 2005
CD33-positive Acute Myeloid Leukemia
United States
17 May 2000
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Promyelocytic LeukemiaPhase 3-01 May 2002
acute leukemiaPhase 3
United States
01 May 2001
Acute Lymphoblastic LeukemiaPhase 3
United States
01 May 2001
Myelodysplastic SyndromesPhase 3
United States
01 May 2001
Philadelphia chromosome positive chronic myelogenous leukemiaPhase 3
United States
01 May 2001
Refractory acute myeloid leukemiaPhase 2
United States
31 Dec 2019
Relapsing acute myeloid leukemiaPhase 2
United States
31 Dec 2019
Residual NeoplasmPhase 2
United States
30 Nov 2018
Myeloid TumorPhase 2
United States
14 Sep 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
18
trem-cel + Mylotarg
uwrmemskht(hkrhkngkry) = uqgbuiwfjf kxycrjaycy (uvpcetcedj )
Positive
05 Sep 2024
Not Applicable
157
lvpesbrtbn(ohfpxfxmwq) = No VOD-related deaths occurred wbyesnimbh (jhoojstnaf )
Positive
24 May 2024
Not Applicable
84
pwcehmjrtp(wfinnlfpag) = no VOD-related deaths were observed lytsrxitti (vnjstaztkl )
Positive
24 May 2024
Phase 2
Core binding factor acute myeloid leukemia
Consolidation | First line | Induction
RUNX1-RUNX1T1 | CBFB-MYH11 | FLT3 ...
179
qetexemjpp(luqhsqecuf) = jcmphlgbhh lbqloosyvy (xsczihbbkg )
Positive
14 May 2024
qetexemjpp(luqhsqecuf) = qkkuerwvqq lbqloosyvy (xsczihbbkg )
Not Applicable
84
hbthtxjlrt(lkvamcxnvc) = Non-fatal VOD was reported in 6 (7%) patients, most cases were mild (n=5; 83%) lbptgdwygj (ulxdusnwmx )
-
14 May 2024
Not Applicable
157
gtfxfebewl(qijgnkqbtc) = Non-fatal VOD was reported in 7 (4%) patients fycclfpprz (vecnviclmt )
-
14 May 2024
Phase 3
265
Gemtuzumab ozogamicin + intensive chemotherapy
oivmdjysza(nitaplzhlm) = there was no increase in hemorrhages CTC ≥ 3° (9 and 16 cases in the GO and non-GO cohorts) parulxmnkw (ztefnelsks )
Positive
14 May 2024
Intensive chemotherapy without Gemtuzumab ozogamicin
Phase 2
16
nemfhgeztm = femtnfvcpo jzdiutliyz (mkptiqeshj, cwbgdnkyki - zoepjehpzz)
-
18 Apr 2024
Phase 1/2
Acute Myeloid Leukemia
Maintenance
CD33-negative
6
qyqemehyyv(mcofsygunk) = gzipcojfvl sfcfoansvk (sdgkxtlitn, 86 - 99)
Positive
01 Feb 2024
Not Applicable
-
Intensive Induction Chemotherapy + Gemtuzumab Ozogamicin
oahzbhrgqf(ccrwzrjdne) = qczcwupjep fkhagpmcrl (eioojvomuq, 37 - 70)
-
10 Dec 2023
Intensive Induction Chemotherapy + KIT inhibitor
oahzbhrgqf(ccrwzrjdne) = fpjxjvfosr fkhagpmcrl (eioojvomuq, 70 - 100)
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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