Mylotarg
(Gemtuzumab ozogamicin)Phase 3Antibody–drug conjugate
Gemtuzumab ozogamicin is used to treat acute myeloid leukemia, a blood cancer. It works by targeting and destroying cancer cells that have a specific protein on their surface.[1] Mylotarg is currently being investigated across 12 indications[3], with its most advanced program in Phase 3.[1]
Mylotarg is one of 251 small molecule programs targeting Leukemia. It is currently in Phase 3.
12
Indications
76
Total Trials
15
Active Trials
250
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[3][1]
Indication
Showing 10 of 12 indications
Competition
Competitive Landscape
804 competitors in Acute Myeloid Leukemia
#DrugCompanyPhaseTrials
1Mylotarg
WWyeth-Lederle Vaccines
Phase 3
Fludara
SanofiPhase 3
Vanflyta
Daiichi SankyoPhase 3
Peony
TakedaPhase 3
Trisenox
CCephalon
Phase 3
Bicnu
MMelissa K Accordino
Phase 3
Active Comparator
ModernaPhase 3
Valspodar
EEastern Cooperative Oncology Group
Phase 3
GM-CSF
YY-mAbs Therapeutics
Phase 3
Azacitadine
AbbViePhase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Acute Myeloid Leukemia36 trials
Show 33 more trials
Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00052299·472 enrolled
Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia
Active, not recruiting·—·Phase 2·NCT03374332·11 enrolled
Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2/3·NCT00091234·279 enrolled
Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00006122·106 enrolled
Myelodysplastic Syndrome6 trials
Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00077116·31 enrolled
Myelodysplastic Syndromes4 trials
Acute Promyelocytic Leukemia4 trials
21 more indications
Newly Diagnosed2 trials
AML2 trials
Relapsed or Refractory1 trial
Allogeneic Stem Cell Transplantation1 trial
Bone Marrow Transplantation1 trial
R/R AML1 trial
Myeloid Neoplasm1 trial
Stem Cell Transplantation1 trial
Elderly Patients1 trial
Acute Lymphoblastic Leukemia1 trial
CLL1 trial
Effects of Chemotherapy1 trial
Immunotherapy1 trial
Chemotherapy1 trial
Core Binding Factor Acute Myeloid Leukemia1 trial
Acute Myeloid Leukaemia1 trial
Regulatory
FDA Approval Timeline[4]
Sep 1, 2017
MYLOTARG
BLA BLA761060
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Gemtuzumab ozogamicin. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Myeloid Cell Surface Antigen CD33 Binding Agent[2]
- Modality
- Antibody–drug conjugate[2]
- Highest Phase
- Phase 3[1]
- Company
- WWyeth-Lederle Vaccines