SPRYCEL
Details
- Status
- Prescription
- First Approved
- 2006-06-28
- Routes
- ORAL
- Dosage Forms
- TABLET
SPRYCEL Approval History
What SPRYCEL Treats
2 indicationsSPRYCEL is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Myeloid Leukemia
- Acute Lymphoblastic Leukemia
SPRYCEL Target & Pathway
ProTarget
An abnormal fusion protein created by a chromosomal translocation, found in chronic myeloid leukemia (CML). BCR-ABL has constitutive kinase activity that drives leukemic cell proliferation. Targeting BCR-ABL transformed CML from a fatal disease to a manageable condition.
SPRYCEL Competitors
Pro4 other drugs also target BCR-ABL. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (BCR-ABL). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to SPRYCEL
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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.
SPRYCEL FDA Label Details
ProIndications & Usage
FDA Label (PDF)SPRYCEL (dasatinib) is indicated for the treatment of adult patients with • newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. • chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 year of age and older with • Ph+ CML in chronic phase. • newly diagnosed Ph+ ALL in com...
SPRYCEL Patents & Exclusivity
Patents (72 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.