ALECENSA
Details
- Status
- Prescription
- First Approved
- 2015-12-11
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ALECENSA Approval History
What ALECENSA Treats
1 indicationsALECENSA is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
ALECENSA Target & Pathway
ProTarget
A receptor tyrosine kinase that, when mutated or rearranged, drives cancer cell growth. ALK rearrangements occur in about 5% of non-small cell lung cancers. Inhibiting ALK blocks aberrant signaling that promotes tumor survival and proliferation.
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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.
ALECENSA FDA Label Details
ProIndications & Usage
FDA Label (PDF)ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. 1.1 Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC) ALECENSA is indicated as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cance...
ALECENSA Patents & Exclusivity
Patents (5 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.