ONCASPAR
ONCASPAR (pegaspargase) is an asparagine-specific enzyme indicated for use as a component of a multi-agent chemotherapeutic regimen. It is approved for the treatment of both pediatric and adult patients with acute lymphoblastic leukemia (ALL). The medication is utilized as a first-line therapy or for patients who have developed a hypersensitivity to native forms of L-asparaginase.
How ONCASPAR Works
ONCASPAR is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. This action results in the depletion of asparagine levels within the plasma. Leukemic cells with low expression of asparagine synthetase are unable to synthesize their own asparagine and must rely on exogenous sources for survival. By depleting these external sources, the drug facilitates the killing of leukemic cells.
Details
- Status
- Prescription
- First Approved
- 1994-02-01
- Routes
- N/A
- Dosage Forms
- VIAL
ONCASPAR Approval History
What ONCASPAR Treats
2 indicationsONCASPAR is approved for 2 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
- Hypersensitivity
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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.
ONCASPAR FDA Label Details
ProIndications & Usage
FDA Label (PDF)ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia Acute lymphoblastic leukemia and hypersensitivity to asparaginase 1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL. 1.2 Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase ONCASPAR is indicated as a component of a multi-agent chemoth...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.