MYLOTARG
Mylotarg is a CD33-directed antibody-drug conjugate used to treat CD33-positive acute myeloid leukemia (AML). It is indicated for newly-diagnosed patients, including adults and pediatric patients as young as one month old. Additionally, the drug is approved for adults and pediatric patients aged two years and older with relapsed or refractory CD33-positive AML. This therapeutic provides a targeted approach for both treatment-naive and previously treated AML populations.
How MYLOTARG Works
Mylotarg consists of a monoclonal antibody linked to a cytotoxic agent, N-acetyl gamma calicheamicin. The antibody portion targets and binds to the CD33 antigen expressed on the surface of tumor cells, which then triggers the internalization of the drug complex. Once inside the cell, the cytotoxic agent is released through the cleavage of its linker, leading to double-strand DNA breaks. This process results in cell cycle arrest and the programmed death of the leukemia cells.
Details
- Status
- Prescription
- First Approved
- 2017-09-01
- Routes
- SINGLE-DOSE
- Dosage Forms
- VIAL
MYLOTARG Approval History
What MYLOTARG Treats
1 indicationsMYLOTARG is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Myeloid Leukemia
MYLOTARG Boxed Warning
HEPATOTOXICITY Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with MYLOTARG. ( 5.1 and 6.1 ) WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity, including severe or fatal h...
WARNING: HEPATOTOXICITY Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with MYLOTARG. ( 5.1 and 6.1 ) WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG. ( 5.1 , 6.1 )
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MYLOTARG FDA Label Details
ProIndications & Usage
FDA Label (PDF)MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older . • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older . 1.1 Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML) MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. 1.2 Relapsed or Refractory CD33-positive AML MYLOTARG is indicated for t...
WARNING: HEPATOTOXICITY Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequen...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.