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 10 indications[3], with its most advanced program in Phase 3.[1]
Mylotarg is one of 196 small molecule programs targeting Myeloid Leukemia. It is currently in Phase 3.
10
Indications
77
Total Trials
15
Active Trials
195
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[3][1]
Indication
Competition
Competitive Landscape
255 competitors in Acute Myeloid Leukemia
#DrugCompanyPhaseTrials
1Idamycin
PfizerPhase 3
Xospata
AstellasPhase 3
Fludara
SanofiPhase 3
Mylotarg
WWyeth-Lederle Vaccines
Phase 3
Vepesid
AAvyxa
Phase 3
Vanflyta
Daiichi SankyoPhase 3
Neupogen
EEastern Cooperative Oncology Group
Phase 3
Cerubidine
HHikma Pharmaceuticals LLC
Phase 3
Nexavar
BayerPhase 3
Trexall
Jazz PharmaceuticalsPhase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Acute Myeloid Leukemia38 trials
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
Show 35 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
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
Acute Promyelocytic Leukemia4 trials
Myelodysplastic Syndromes4 trials
Myelodysplastic Syndrome4 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
23 more indications
AML2 trials
Acute Lymphoblastic Leukemia1 trial
R/R AML1 trial
CLL1 trial
Myeloid Neoplasm1 trial
Elderly Patients1 trial
Allogeneic Stem Cell Transplantation1 trial
Effects of Chemotherapy1 trial
Bone Marrow Transplantation1 trial
Relapsed or Refractory1 trial
Stem Cell Transplantation1 trial
Immunotherapy1 trial
Chemotherapy1 trial
Core Binding Factor Acute Myeloid Leukemia1 trial
Leukemia, Myeloid, Acute1 trial
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome1 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