BLASINGLE-DOSEVIAL
Approved
Sep 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
27
Data completeness
3/8 — Basic
MYLOTARG (gemtuzumab ozogamicin) by Pfizer is cd33-directed antibody interactions [moa]. First approved in 2017.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYLOTARG (gemtuzumab ozogamicin) is a CD33-directed antibody-drug conjugate (ADC) that binds to CD33 antigen on acute myeloid leukemia (AML) cells and delivers cytotoxic payload intracellularly. It is administered as a single-dose intravenous infusion and represents a targeted immunotherapy approach for hematologic malignancies. The mechanism combines monoclonal antibody specificity with direct cytotoxic activity.
Peak
Product is at peak commercial maturity with moderate competitive intensity (30/100), suggesting stable but increasingly defended market positioning requiring experienced brand protection and strategic commercial execution.
Mechanism of Action
CD33-directed Antibody Interactions
Pharmacologic Class:
CD33-directed Immunoconjugate
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (27)
A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia
Started Dec 2023
165 enrolled
Acute Myeloid Leukemia
A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML
Started Jun 2023
19 enrolled
AMLLeukaemia (Acute Myeloid)
CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML
Started Feb 2023
18 enrolled
Acute Myeloid Leukemia
Allogeneic Engineered Hematopoietic Stem Cell Transplant (HCT) Lacking the CD33 Protein, and Post-HCT Treatment With Mylotarg, for Patients With CD33+ AML or MDS
Started Dec 2021
67 enrolled
Leukemia, Myeloid, AcuteMyelodysplastic Syndromes
Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)
Started Apr 2021
28 enrolled
Acute Myeloid Leukemia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.