Floatz Rating
B63/100
Confidence
Indicative
Sponsor
Shaare Zedek Medical Center
Modality
antibody_drug_conjugate
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
66High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05599360CT.gov Vyxeos for Induction of Low- or Intermediate-risk. | — | Active Not Recruiting | — | — | — |
NCT04849910CT.gov Allogeneic Engineered Hematopoietic Stem Cell Transplant (HCT) Lacking the CD33 Protein, and Post-HCT Treatment With Mylotarg, for Patients With CD33+ AML or MDS | — | Terminated | — | — | — |
NCT02272478CT.gov Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations | — | Unknown | — | — | — |
NCT01698879CT.gov Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment | — | Completed | — | — | — |
NCT00927498CT.gov A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old | — | Completed | — | — | — |
NCT02182596CT.gov DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML | — | Completed | — | — | — |
NCT01723657CT.gov Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML) | — | Completed | — | — | — |
NCT00195000CT.gov Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS | — | Completed | — | — | — |
NCT00304447CT.gov Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia | — | Completed | — | — | — |
NCT00161668CT.gov Study Evaluating Mylotarg (Gemtuzumab Ozogamicin) in Usual Care | — | Completed | — | — | — |
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NCT00038831CT.gov Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Myeloid Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Mylotarg (this asset) | Shaare Zedek Medical Center | Approved | B · 63 |
| Gemtuzumab | M.D. Anderson Cancer Center | P4 | A |
| Amsacrine | University Hospital, Toulouse | P4 | BBB |
| Posaconazole | AstraZeneca | P4 | BBB |
| (+)-Vincristine | Janssen Research & Development, LLC | P3 | BBB |
| Aclacinomycin | Chinese PLA General Hospital | P4 | BB |
| Alvocidib | M.D. Anderson Cancer Center | P2 | BB |
| Prednisone | Children's Oncology Group | P3 | BB |
| Therapeutic Allogeneic Lymphocytes | University of Southern California | P2 | BB |
+42 more in the Acute Myeloid Leukemia cohort
Other indications for Mylotarg
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Myelodysplastic Syndrome | — | P2/3 | B · 60 |
| Acute Promyelocytic Leukemia | — | P2 | CCC · 53 |
| Leukemia | — | P2/3 | CCC · 50 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Mylotarg in Acute Myeloid Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/mylotarg-acute-myeloid-leukemia
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