ZELBORAF
Details
- Status
- Prescription
- First Approved
- 2011-08-17
- Routes
- ORAL
- Dosage Forms
- TABLET
ZELBORAF Approval History
What ZELBORAF Treats
2 indicationsZELBORAF is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Melanoma
- Erdheim-Chester Disease
ZELBORAF Target & Pathway
ProTarget
A kinase in the MAPK signaling pathway that regulates cell growth. BRAF mutations (especially V600E) occur in melanoma, colorectal, and thyroid cancers, causing uncontrolled cell proliferation. Inhibiting mutant BRAF blocks this aberrant growth signal.
ZELBORAF Competitors
Pro6 other drugs also target BRAF. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (BRAF). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
ZELBORAF FDA Label Details
ProIndications & Usage
FDA Label (PDF)ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma 1.1 Unresectable or Metastatic Melanoma ZELBORAF ® is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Limitation of Use:...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.