TABRECTA (capmatinib hydrochloride)
TABRECTA is indicated for the treatment of Metastatic non-small cell lung cancer (NSCLC) with a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping.
How TABRECTA Works
Capmatinib targets the MET receptor, including the mutant variant produced by exon 14 skipping. This mutation results in a protein missing a regulatory domain, which leads to increased downstream signaling and tumor cell growth. By inhibiting MET phosphorylation and downstream signaling proteins, the drug prevents the proliferation and survival of MET-dependent cancer cells. It has demonstrated anti-tumor activity in models with mutations leading to MET exon 14 skipping or MET amplification.
Details
- Status
- Prescription
- First Approved
- 2020-05-06
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- TABLET
TABRECTA Approval History
What TABRECTA Treats
1 indicationsTABRECTA is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic non-small cell lung cancer (NSCLC) with a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping
TABRECTA Target & Pathway
ProTarget
TABRECTA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TABRECTA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TABRECTA treats. First-in-class if their pivotal trials read out positive.
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.
TABRECTA FDA Label Details
Indications & Usage
FDA Label (PDF)TABRECTA is indicated for the treatment of Metastatic non-small cell lung cancer (NSCLC) with a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping.
TABRECTA Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TABRECTA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 28 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.