TAFINLAR
Details
- Status
- Prescription
- First Approved
- 2013-05-29
- Routes
- ORAL, ORAL SUSPENSION
- Dosage Forms
- CAPSULE, TABLET, TABLET, FOR SUSPENSION
TAFINLAR Approval History
What TAFINLAR Treats
4 indicationsTAFINLAR is approved for 4 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Melanoma
- Non-Small Cell Lung Cancer
- Anaplastic Thyroid Cancer
- Solid Tumors
TAFINLAR Target & Pathway
ProTarget
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
TAFINLAR Competitors
Pro10 other drugs also target EGFR. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (EGFR). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to TAFINLAR
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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.
TAFINLAR FDA Label Details
ProIndications & Usage
FDA Label (PDF)TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. TAFINLAR is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. the treatment of patie...
TAFINLAR Patents & Exclusivity
Patents (120 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.