ASPARLAS
ASPARLAS (calaspargase pegol-mknl) is an asparagine-specific enzyme indicated for the treatment of acute lymphoblastic leukemia. It is administered as one component of a multi-agent chemotherapeutic regimen. The therapy is specifically approved for use in pediatric and young adult patients between the ages of 1 month and 21 years.
How ASPARLAS Works
This drug is an L-asparaginase enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. Its therapeutic effect is derived from the depletion of plasma asparagine, which leukemic cells require for survival. Because these malignant cells have low expression of asparagine synthetase, they lack the ability to synthesize the amino acid internally. Depleting the exogenous source of asparagine leads to the death of the leukemic cells.
Details
- Status
- Prescription
- First Approved
- 2018-12-20
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
ASPARLAS Approval History
What ASPARLAS Treats
1 indicationsASPARLAS is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
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Active Pipeline
Ongoing clinical trials by development phase
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.
ASPARLAS FDA Label Details
ProIndications & Usage
FDA Label (PDF)ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. 1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.